Prophylactic Antibiotics in Measles

February 25, 2008 updated by: Bandim Health Project

Prophylactic Antibiotics in Measles Infection. A Community-Based Randomised Double-Blind Placebo-Controlled Trial in Guinea-Bissau

Objective It is the objective to test whether the use of prophylactic antibiotics in measles infection will reduce the incidence of post-measles pneumonia and/or admissions to hospital with 50%. The possible impact on other complications of severe measles will also be measured.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background The case-fatality rate of measles in developing countries is still high, particularly in infants. It is estimated that measles is responsible for more than one million deaths per year, and that most of these deaths are due to complications of the disease.

Most of the severe complications of measles in developing countries are due to secondary bacterial and viral infections causing pneumonia and diarrhea.

A study from the fifties showed no benefit from treating measles cases prophylactically with antibiotics, and this together with the fear for developing antibiotic resistance has given rise to the dogma that it is harmful to give prophylactic antibiotics in measles infection.

A more recent study from Niakhar, a rural area of Senegal, has shown that children treated with prophylactic antibiotics had a lower frequency of respiratory complications. In 1987 it was decided that all children younger than 3 years of age seen within the first 2 weeks of the onset of measles symptoms should be treated with the antibiotic trimethoprim-sulfamethoxazole for 7 days irrespective of whether they had signs of bacterial infection at the time of clinical examinations. Children younger than 3 years of age who had received prophylactic antibiotics were less likely to have respiratory symptoms on days 8 to 15 of illness than children of the same age group who had not received antibiotics because they were seen for the first time on days 8 to 15 (relative risk, 0.37 (0.15 to 0.94)). Further, the case-fatality rates adjusted for age declined 2-fold between 1983-1986 and between 1987-1991 (mortality ratio, 0.41 (0.21 to 0.81)).

As this study was not an unbiased evaluation, it would be desirable to do a randomized doubleblind placebocontrolled trial of prophylactic use of antibiotics in measles infection. This could potentially prevent a large number of measles-related complications and deaths.

Participation and randomization Measles cases included in the study will receive treatment with either co-trimoxazole or the identical looking placebo. The co-trimoxazole and the placebo will be packed in identical looking sacks marked with a randomization number. The code will be broken only after the end of the study period.

Informed consent will be obtained from the parents or guardians. It will be explained that the study will examine whether antibiotics can prevent later complications, it is not known whether this is indeed the case. Therefore there will be one group receiving active treatment, and another group receiving placebo, and we do not know to which group the measles case belongs. It will also be explained if they do not want to participate, the management of the measles case will be as otherwise done in the study area.

Measles cases not included in the study will receive standard treatment.

Study Type

Interventional

Enrollment

218

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Guinea-Bissau
    • Apartado 861
      • Bissau, Apartado 861, Guinea-Bissau, 1004 Bissau Codex
        • Bandim Health Project

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A clinical diagnosis of probable measles in the prodromal phase or within the first seven days of the onset of the rash

Exclusion Criteria:

  • Pregnant and nursing women
  • Children less than 2 months old
  • Children who need urgent referral to the hospital, children with bacterial infections of the lung, or children with another bacterial infection requiring systemic antibiotic treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Post-measles pneumonia
Admission to hospital

Secondary Outcome Measures

Outcome Measure
Weight gain or loss during the first month of infection
Diarrhoea
Severe fever
Oral thrush
Stomatitis
Conjunctivitis
Otitis media

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bandim Health Project

Collaborators

Medical Research Council Unit, The Gambia

Investigators

  • Study Director: PETER AABY, MSc, Dr Med, Bandim Health Project
  • Principal Investigator: MAY-LILL GARLY, PHD, DTM&H, Bandim Health Project

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1998

Primary Completion (Actual)

October 1, 2001

Study Completion (Actual)

October 1, 2001

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

February 26, 2008

Last Update Submitted That Met QC Criteria

February 25, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ProfAnt-BHP-1996

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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