Prophylactic Antibiotics in Measles
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00168532|
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : February 26, 2008
|Condition or disease||Intervention/treatment||Phase|
|Post-Measles Pneumonia Measles||Drug: Sulfamethoxazole-Trimethoprim||Phase 3|
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 (Clinical Trial)|
|Enrollment :||218 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Prophylactic Antibiotics in Measles Infection. A Community-Based Randomised Double-Blind Placebo-Controlled Trial in Guinea-Bissau|
|Study Start Date :||January 1998|
|Actual Primary Completion Date :||October 2001|
|Actual Study Completion Date :||October 2001|
- Post-measles pneumonia
- Admission to hospital
- Weight gain or loss during the first month of infection
- Severe fever
- Oral thrush
- Otitis media
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00168532
|Bandim Health Project|
|Bissau, Apartado 861, Guinea-Bissau, 1004 Bissau Codex|
|Study Director:||PETER AABY, MSc, Dr Med||Bandim Health Project|
|Principal Investigator:||MAY-LILL GARLY, PHD, DTM&H||Bandim Health Project|