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Paper

Effectiveness of antibiotics in preventing meningococcal = disease after=20 a case: systematic review

Bernadette = Purcell,=20 specialist registrar1, = Susanne=20 Samuelsson, consultant=20 epidemiologist2, Susan J M=20 Hahn=E9, European Programme for Intervention = Epidemiology=20 training fellow3, Ingrid=20 Ehrhard, consultant=20 microbiologist4, Sigrid=20 Heuberger, consultant=20 microbiologist5, Ivonne=20 Camaroni, European Programme for Intervention = Epidemiology=20 training fellow3, Andr=E9=20 Charlett, head6, = James=20 M Stuart, consultant=20 epidemiologist1=20

1 Communicable Disease Surveillance = Centre=20 South West, Gloucester GL10 3RF, 2 Statens Serum = Institut,=20 Copenhagen, Denmark 2300, 3 Communicable Disease = Surveillance=20 Centre, Cardiff, Wales CF4 3QX, 4 = Landesuntersuchungsanstalt=20 f=FCr das Gesundheits und Veterin=E4rwesen, Dresden, Germany = 01099,=20 5 National Reference Centre for Meningococci, Graz, = Austria=20 A-8010, 6 Public Health Laboratory Service Statistics = Unit,=20 Colindale, London NW9 5EQ

Correspondence to: J Stuart james.stuart{at}hpa.org.uk


   Abstract =
Top
Abstract
Introduction
Methods
Results
Discussion
References
 
<= B>Objective=20 To summarise the evidence for the role of antibiotics = in=20 preventing further cases of meningococcal disease through=20 chemoprophylaxis given to the index patient, household=20 contacts, and children in day care settings after a = single=20 case.

Design Systematic review.

Methods Studies were identified by searching Embase=20 (1983-2003), Medline (1965-2003), and CAB Health = (1973-2003)=20 and by contacting the World Health Organization and the = European meningococcal disease surveillance network and = examining references of identified papers. The review = included=20 all studies with at least 10 cases in which outcomes = were=20 compared between treated and untreated groups. =

Main outcome measure Subsequent cases of meningococcal=20 disease 1-30 days after onset of disease in the index=20 patient.

Results Four observational studies and one small trial = met=20 the inclusion criteria. Meta-analysis of studies on=20 chemoprophylaxis given to household contacts showed a=20 significant reduction in risk (risk ratio 0.11, 95% = confidence=20 interval 0.02 to 0.58). The number needed to treat to = prevent a=20 case was estimated as 218 (121 to 1135). Primary = outcome data=20 were not available in studies of chemoprophylaxis given = to the=20 index patient: when prophylaxis had not been given, = rate of=20 carriage after discharge from hospital was estimated as = 3% (0=20 to 6), probably an underestimate of the true rate. No = studies=20 of chemoprophylaxis in day care settings were = identified that=20 met the inclusion criteria.

Conclusion There have been no high quality experimental=20 trials looking at control policies for meningococcal = disease.=20 The best available evidence is from retrospective = studies. The=20 risk of meningococcal disease in household contacts of = a=20 patient can be reduced by an estimated 89% if they take = antibiotics known to eradicate meningococcal carriage.=20 Chemoprophylaxis should be recommended for the index = patient=20 and all household contacts.


   Introduction =
Top
Abstract
Introduction
Methods
Results
Discussion
References
 
T= he=20 severity of meningococcal disease and its tendency to cause=20 clusters, mainly among household contacts of an index = patient,=20 means strategies to reduce the risk of further cases are = of=20 high priority. However, the lack of evidence for = strategies=20 to control meningococcal disease is a well recognised = obstacle=20 in the development of coherent policies1=20 and is reflected in the variation in approach across=20 Europe.2=20

Chemoprophylactic treatment to eradicate nasopharyngeal = carriage=20 and to interrupt further transmission has been a key = approach=20 to control for more than 50 years.3=20 Most European countries recommend a short course of = rifampicin=20 or ciprofloxacin for all household contacts=97taken = here to mean=20 those people living in the same household or having an=20 equivalent degree of contact with the index patient. = This=20 approach is biologically plausible. The effect of = rifampicin in=20 preventing subsequent cases of meningitis caused by=20 Haemophilus influenzae has, indeed, been = demonstrated in=20 a randomised placebo-controlled trial.4=20 However, the effectiveness of chemoprophylaxis for=20 meningococcal disease has never been demonstrated in=20 experimental research, and evidence cited in support = has been=20 limited to one observational study.5=20 Failures of this approach have been reported,6-8=20 and there is evidence of overprescribing.9=20 A different policy is recommended in Norway, where = household=20 members below 15 years of age are treated as though = they have=20 early meningococcal disease. They are kept at home and = given=20 oral penicillin for seven days, the period of maximum=20 risk.

Some national policies also recommend chemoprophylaxis to = the=20 index case before discharge from hospital, on the premise = that=20 the pathogenic strain may otherwise be reintroduced by the=20 index patient into the household. However, = contradictory=20 findings regarding carriage of the pathogenic = meningococcal=20 strain after full antibiotic treatment of the index = patient are=20 reflected in different recommendations. For example, = policy in=20 Denmark, Norway, and Sweden does not recommend = prophylaxis for=20 the index patient, whereas it is recommended in the = United=20 Kingdom, Canada, the United States, Spain, and = Germany.=20

There are no uniform recommendations as to how contacts = should=20 be managed in day care settings (children aged 0-6 years). = The=20 national control policies of the United Kingdom and = Denmark=20 recommend chemoprophylaxis only after the second case in a = day=20 care setting, whereas other countries such as Ireland, = Sweden,=20 Spain, and Germany recommend chemoprophylaxis after a = single=20 case.

There is a new impetus to improve coordination of = infectious=20 disease control across countries in the European = Union.10=20 A prerequisite for better coordination is a shared=20 understanding of the evidence on which recommendations = for=20 disease prevention and control are based. To further = this aim=20 the European Monitoring Group on Meningococci formed a = working=20 group to conduct a systematic review of interventions = for=20 meningococcal disease where there was greatest = variation=20 between countries. Here we have evaluated the = effectiveness of=20 giving chemoprophylaxis to the index patient and to = contacts in=20 households and childcare settings.


   Methods =
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Abstract
Introduction
Methods
Results
Discussion
References
 
<= STRONG>Study=20 inclusion and characteristics
We included all studies = that had=20 clear intervention and non-intervention groups, = including=20 experimental (randomised and non-randomised trials),=20 observational studies, and case series with a minimum = of 10=20 cases. We excluded case reports and opinions of authorities = or=20 committees. We did not restrict by date, country, or language = of publication. We included in the intervention group = those=20 people who were given prophylactic antibiotic regimens=20 considered effective in eradicating meningococcal = carriage (for=20 example, for adults, rifampicin 600 mg orally twice a = day for=20 two days, ciprofloxacin 500 mg orally single dose, = ceftriaxone=20 250 mg intramuscular single dose). Those not given = prophylactic=20 antibiotics or given antibiotics considered ineffective = at=20 eradicating carriage (for example, penicillin) were = included in=20 the non-intervention group.

The primary outcome was specified a priori as the rate of=20 subsequent cases 1-30 days after an index case, where a = subsequent case was defined as another case among = household=20 contacts of the index patient (or for the day care = analysis as=20 another case in the same day care setting). We included = only=20 those studies that described at least one month of = follow up=20 after the index case. The other main outcome of = interest was=20 the rate of nasopharyngeal carriage of the pathogenic = organism=20 in the index patient on discharge from hospital. =

Search strategy
We searched the Cochrane = register=20 of trials and systematic reviews, the database of = abstracts of=20 reviews of effectiveness, the health technology = assessment and=20 the national research register in England and Wales, = Medline=20 1966-2003, Embase 1983-2003, and CAB Health 1973-2003. = The text=20 word terms and MESH headings used were: meningococcal=20 infections, Neisseria meningitidis, = chemoprevention,=20 prophylaxis, chemoprophylaxis, antibiotics, drug = therapy,=20 primary health care, patient care management, community = health=20 services, communicable disease control, disease = outbreaks,=20 disease transmission, cluster, outbreak, carrier state, = cases,=20 household. We checked bibliographies of existing = reviews and=20 the identified studies. We contacted the Cochrane Acute = Respiratory Infections group, the World Health Organization,=20 and the European Monitoring Group on Meningococci. =

Data extraction and synthesis
The full = texts of all=20 potentially relevant articles were obtained and two = reviewers=20 independently checked the data. If more than one paper = with the=20 same data was identified only that which contained the=20 definitive data was included. A third reviewer from the = group=20 was available to resolve any disagreements.

Statistical methods
The meta-analyses were=20 performed with the "meta" command in Stata (StataCorp, = College=20 Station, TX).11=20 Combined estimates of the risk ratio and the absolute = risk=20 reduction (or risk difference) were obtained by = assuming that=20 the treatment effects from the different studies had a=20 distribution (random effect) rather than a common = treatment=20 effect (fixed effect). In those studies where there = were no=20 cases in either the treated or untreated groups we = added 0.5 to=20 all four cells. When there were no cases in the = intervention=20 and control groups, we did not estimate risk ratios and = the=20 study was excluded from the pooled risk ratio. We used = the=20 DerSimonian and Laird approach, in which an estimate of = variation within studies is combined with an estimate = of=20 variation between studies.

To estimate the pooled relative risk we used the natural = logarithm=20 and back transformed results to obtain an estimated = relative=20 risk. The number needed to treat was the reciprocal of the=20 estimated absolute risk reduction. We used a fixed = effect=20 approach with an inverse variance method to pool the = carriage=20 rates. The effects were pooled in the same manner in = the two=20 groups. We tested statistical heterogeneity with 3D{chi}=202 tests,=20 with pre-specified potential sources of = heterogeneity.=20


   Results =
Top
Abstract
Introduction
Methods
Results
Discussion
References
 
T= he=20 search identified 2606 papers. After reviewing titles and=20 abstracts we retrieved 102 as potentially relevant. Of = these,=20 five studies met the criteria for this review. Of the = excluded=20 reports, many were descriptive accounts of outbreaks and = case=20 reports, some addressed a different set of questions or = did=20 not evaluate an intervention, and others did not report = the=20 outcomes of primary interest or had no comparison group. = We=20 did not identify any studies of day care and nursery = schools=20 that met our criteria.

Evidence of benefit from chemoprophylaxis to household=20 contacts
Five studies satisfied our inclusion = criteria, four=20 retrospective cohort studies and one small = trial.5=20 12-15=20 In total they involved 1249 sporadic cases of = meningococcal=20 disease and about 4271 household contacts. The only=20 experimental study was a small randomised trial within = a larger=20 seroepidemiological survey.12=20 Fifty four contacts from 11 affected households were = randomised=20 to receive rifampicin (35) or no treatment (19). No = subsequent=20 cases occurred in either group after nine months (table=20 1).


View this=20 table:
[= in=20 this window]
[in a new window]
  = 		Table 1 = Effectiveness of=20 antibiotics to contacts after case of meningococcal = disease:=20 study characteristics =

 = ;

The largest and most frequently cited study used enhanced=20 surveillance of a case series in 27 US states between = 1973 and=20 1974.5=20 This paper partly duplicated earlier findings.16=20 They found an attack rate of 4.2/1000 among untreated = household=20 contacts and no cases among treated contacts (table=20 2). This difference suggests that chemoprophylaxis = is=20 effective (relative risk 0.15, 95% confidence interval = 0.01 to=20 2.79) but not significant.


View this=20 table:
[= in=20 this window]
[in a new window]
  = 		Table 2 Estimate of = effect of=20 chemoprophylaxis given to household contacts after = sporadic=20 case of meningococcal disease =

 = ;

In a survey of meningococcal disease in the Netherlands = from=20 April 1989-May 1990,14=20 a secondary objective was to assess the attack rate = among=20 household contacts and document the uptake of = chemoprophylaxis.=20 Although it was not official policy to give = chemoprophylaxis in=20 the Netherlands during the study period, 55% (627 = people from=20 220 families) of close contacts had received = antibiotics. There=20 were 502 primary cases reported during the study = period.=20 Information was available on 1130 household contacts in = 75%=20 (378) of these cases, and on antibiotics for 98% (1102) = of=20 these contacts. In the 30 day period after occurrence of = the=20 index case, there were four subsequent cases among 826 = contacts=20 that did not receive adequate chemoprophylaxis (including = two=20 in people who received penicillin) and no cases among 276 = who=20 had "optimal" treatment (0.33, 0.02 to 6.14, table=20 2).

In a study to evaluate the efficiency of the = implementation=20 of prophylactic measures in Denmark,15=20 there were no cases among 724 treated contacts and two = among 72=20 who were not treated (0.02, 0.00 to 0.42, table=20 2). The two subsequent cases were in friends of the = index=20 patients who had slept in the same room as their = respective=20 index case. No further information was available on 56% = of=20 cases (table=20 1).

Kristiansen's study, among the 165 000 inhabitants of = Telemark=20 in Norway, examined whether a policy of targeted = prophylaxis=20 with rifampicin for contacts carrying the meningococcal = strain=20 that caused the disease could limit the spread of = infection=20 more efficiently than treatment with penicillin alone to=20 household members aged under 15 years.13=20 No subsequent cases occurred among 441 potential = contacts=20 screened and treated with rifampicin compared with 15 = (11=20 confirmed) cases in 1984-87, when only penicillin was = given.=20 Although this study suggests benefit from the targeted=20 intervention, we could not measure risk reduction as = the number=20 of contacts was not available for the earlier time = period. The=20 follow up period was much longer and the contact = definitions=20 were much broader than the definitions used for our=20 review.

Summary effect estimates for chemoprophylaxis versus no = treatment
Three studies, in the United States, = Denmark, and=20 the Netherlands, had sufficiently similar = characteristics=20 (clinical homogeneity) for inclusion in the=20 meta-analysis.5=20 14=20 15=20 We did not include Kaiser's study12=20 as there were no events in treatment or intervention=20 group.

The summary risk ratio was 0.11 (0.02 to 0.58; figure).=20 This implies that chemoprophylaxis given to household = contacts=20 after a case of meningococcal disease reduces the risk = of=20 subsequent cases by 89%. Results of tests for = heterogeneity=20 were not significant (P =3D 0.39). The pooled absolute = risk=20 reduction was 46/10 000 (9/10 000 to 83/10 000), and = the number=20 needed to treat to prevent a case was estimated as 218 = (121 to=20 1135).


<= IMG=20 height=3D76 alt=3D" " hspace=3D10=20 = src=3D"http://bmj.bmjjournals.com/content/vol328/issue7452/images/small/1= 11096purb.f1.gif"=20 width=3D200 vspace=3D5 border=3D2>
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  = 		Effect of chemoprophylaxis = given to=20 household contacts after a case of meningococcal = disease on=20 risk of subsequent cases: pooled risk ratio =

 = ;

Evidence for use of chemoprophylaxis in index patients = before=20 discharge from hospital
We found no studies comparing = index=20 patients given chemoprophylaxis with those who were = not. Four=20 studies assessed persistent meningogcoccal carriage on=20 discharge from hospital in patients who had not = received=20 chemoprophylaxis. Alvez et al showed that three of 48 = children=20 (aged 3 months to 13 years) who were treated with 300 = 000=20 units/kg/day of penicillin G sodium intravenously for = at least=20 10 days were carriers of Neisseria meningitidis = on=20 discharge.17=20 In the study of Abramson and Spika meningococci were = cultured=20 from the upper respiratory tract in one of 14 patients=20 discharged after completion of intravenous therapy, = initially=20 with ampicillin or chloramphenicol then benzyl penicillin.18=20 Four patients had positive cultures one week after the end = of=20 treatment. The household contacts of the patients, but not = the=20 patients themselves, had received chemoprophylaxis with=20 rifampicin. Barroso found two of 51 patients had = positive=20 nasopharyngeal swabs after the end of their = treatment,19=20 though the exact timing of the swabs in relation to = hospital=20 discharge (eight hours after the end of treatment to = six days=20 after discharge) is not clear. The patients had been = treated=20 with ampicillin, penicillin, or chloramphenicol. Weis = found no=20 carriers among 47 patients on discharge.20=20 Although this study did not specify the antibiotic = treatment=20 used, benzyl penicillin was then the standard treatment = for=20 meningococcal disease in Denmark (S Samuelsson, personal=20 communication).

The four studies were included in meta-analysis. Results = of=20 tests for heterogeneity were not significant (P =3D 0.35). = The=20 pooled estimate from these studies was calculated as 0.03 = (0.00=20 to 0.06, table=20 3).


View this=20 table:
[= in=20 this window]
[in a new window]
  = 		Table 3 Estimated = carriage=20 rate on discharge from hospital in index patients not = treated=20 with chemoprophylaxis. Meta-analysis results =

 = ;


   Discussion =
Top
Abstract
Introduction
Methods
Results
Discussion
References
 
W= e=20 found that if household contacts of a patient with = meningococcal=20 disease are given prophylaxis with antibiotics that = eradicate=20 meningococcal carriage there are fewer subsequent cases. = The=20 reduction in risk is considerable. We estimate that about = 200=20 household contacts need to be treated to prevent a = subsequent=20 case during the first month. This applies to a strategy of=20 giving chemoprophylaxis to a network of household = contacts but=20 provides no evidence to support indiscriminate = prescribing of=20 antibiotic prophylaxis to people outside this = group.=20

The main difficulty in interpreting the findings is that = they=20 are obtained from retrospective observational studies. = Risk=20 factors for meningococcal disease, such as young age, male = sex,=20 passive smoking, and lower socioeconomic status, are all=20 potential confounding factors.21=20 22=20 None of the studies took account of these factors in = their=20 analysis. There is evidence that people of lower = socioeconomic=20 status are less likely to receive preventive=20 interventions.23=20 If this were the case for meningococcal disease, these=20 observational studies would overestimate the true benefit = of=20 treatment. On the other hand, adults have a lower baseline = risk=20 of disease and if children were more likely to get = prophylaxis=20 than adults this would underestimate the true effect. The=20 studies gave no baseline comparisons of age = distribution=20 between treated and untreated groups. If efforts to = achieve=20 follow up had differed in some way between treated and=20 untreated groups, this would only dilute the observed = effect of=20 treatment, unless the investigators had somehow applied = different stringency of criteria (for instance, for = case=20 definitions) between groups. The risk to untreated = household=20 contacts is highest in the first week after the index = case and=20 declines rapidly thereafter.24=20 A one month period to measure risk reduction is = therefore=20 reasonable but does not assess whether chemoprophylaxis = could=20 prevent subsequent cases beyond this period.25=20

Previous studies have suggested that subsequent cases may = be=20 caused by reintroduction of the virulent strain to the=20 household by the index patient.26=20 We estimate that about 3% of index patients treated = with=20 penicillin and who have not received chemoprophylaxis = will=20 still be carrying the virulent strain on discharge from=20 hospital. As carriage may be suppressed but not eradicated = by=20 penicillin treatment so that carriage is less easily = detected=20 on completion of treatment,18=20 this figure is likely to underestimate the true = carriage rate=20 among index patients. Giving chemoprophylaxis to the = index=20 patient before discharge from hospital should also be=20 supported, unless they have already been treated with an=20 antibiotic such as ceftriaxone, which is known to = eradicate=20 carriage.

Studies to estimate the effect of chemoprophylaxis in day = care=20 settings are needed, and the current variation in policy = across=20 European countries is therefore not surprising. As = clusters=20 are unusual in this setting and as policies vary by = country,=20 a multinational study may be needed to provide evidence on=20 benefit.

This is the first systematic review of evidence for = control=20 policies for meningococcal disease and supports giving a = short=20 course of antibiotics that eradicate carriage to household=20 contacts and index patients. The consistency of the = study=20 findings, the size of the risk ratio, and the = biological=20 plausibility of this approach lend further weight to = our=20 conclusions. We believe that such a policy should be = applied=20 across Europe and other industrialised countries. =


What = is already=20 known on this topic

A lack of evidence for strategies to = control=20 meningococcal disease has resulted in a = variation=20 in approach among countries in Europe

Most countries recommend a short course = of=20 rifampicin or ciprofloxacin for all = household=20 contacts but evidence to support this has = previously=20 been limited to one observational study

There are no uniform recommendations for = giving=20 chemoprophylaxis to the index patient or to = contacts in childcare settings

What this study adds

Evidence from three studies supports the = use of=20 chemoprophylaxis to prevent further cases = of=20 meningococcal disease

The risk of further cases during the = first month=20 is reduced by 89%, and to prevent one case = about=20 200 household contacts need to be treated

After treatment of disease with = penicillin and=20 without giving chemoprophylaxis, at least = 3% of=20 index patients will be carrying the virulent=20 meningococcal strain on discharge from hospital

There are insufficient studies to = estimate the=20 effect of chemoprophylaxis in childcare = settings =

Julie Christmas and Potenza Atiogbe = helped=20 with the search strategy and database searches. Maria=20 Santamaria reviewed the initial dataset. Matthias Egger = gave=20 advice on the methods and earlier drafts.

Contributors: JMS conceived the = study. All=20 authors except AC contributed to the design of the = study,=20 carried out searches, and extracted data. AC performed = the=20 meta-analyses. BP wrote the first draft. All authors = were=20 involved in the writing of the final draft. JMS is = guarantor=20 for this study.

Funding: During part of this = study, SJMH=20 and IC were funded by the European Programme for = Intervention=20 Epidemiology Training (EPIET), which is funded by the = European=20 Commission under the agreement numberSI2.74030 = (99CVVF4-003-0).=20 Two meetings of the working group were supported by = Wyeth=20 Lederle.

Ethical approval: Not = required.


   References =
Top
Abstract
Introduction
Methods
Results
Discussion
References
&nb= sp;

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(Accepted 1 April 2004)




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Lucina
Arch. Dis. Child.,=20 December 1, 2004; 89(12): 1182 - 1182.
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Other = articles=20 noted
Evid. Based Med., = September 1, 2004;=20 9(5): e5 - e5.
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23 Apr 2004 = to 23 Jul=20 2004
Evid. Based Nurs., = October 1, 2004; 7(4):=20 e4 - e4.
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Chemoprophylaxis Really=20 Does Prevent Meningococcal Disease
Journal Watch = (General), July 9, 2004; 2004(709): 3 - 3.
[Full=20 Text]
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Prevention = of=20 Meningococcal Infection in Household = Contacts
Journal=20 Watch Infectious Diseases, June 28, 2004; = 2004(628): 3 -=20 3.
[Full=20 Text]
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Rapid Responses:

Read = all Rapid=20 Responses=20

Licencing of prophylaxis treatments.=20
Richard L Puleston=20
bmj.com, 14 Jun 2004 [Ful= l=20 text]=20
Management of contacts of meningococcal infection = =96 is it=20 evidence based?=20
North East London Public Health, et al.=20
bmj.com, 27 Jul 2004 [Ful= l=20 text]

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