Trial record 1 of 110 for:    "Measles"
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Prophylactic Antibiotics in Measles

This study has been completed.
Sponsor:
Collaborator:
Medical Research Council Unit, The Gambia
Information provided by:
Bandim Health Project
ClinicalTrials.gov Identifier:
NCT00168532
First received: September 9, 2005
Last updated: February 25, 2008
Last verified: February 2008
  Purpose

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.


Condition Intervention Phase
Post-Measles Pneumonia
Measles
Drug: Sulfamethoxazole-Trimethoprim
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Prophylactic Antibiotics in Measles Infection. A Community-Based Randomised Double-Blind Placebo-Controlled Trial in Guinea-Bissau

Resource links provided by NLM:


Further study details as provided by Bandim Health Project:

Primary Outcome Measures:
  • Post-measles pneumonia
  • Admission to hospital

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

Estimated Enrollment: 218
Study Start Date: January 1998
Study Completion Date: October 2001
Primary Completion Date: October 2001 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   3 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00168532

Locations
Guinea-Bissau
Bandim Health Project
Bissau, Apartado 861, Guinea-Bissau, 1004 Bissau Codex
Sponsors and Collaborators
Bandim Health Project
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
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. May-Lill Garly, PhD DTM&H, Bandim Health Project
ClinicalTrials.gov Identifier: NCT00168532     History of Changes
Other Study ID Numbers: ProfAnt-BHP-1996
Study First Received: September 9, 2005
Last Updated: February 25, 2008
Health Authority: Guinea-Bissau: Ministry of Health
Gambia: MRC Ethics Committee

Keywords provided by Bandim Health Project:
Prophylactic antibiotics
Measles
Pneumonia
Post-measles pneumonia
Low income country
Guinea-Bissau
Bandim Health Project

Additional relevant MeSH terms:
Measles
Pneumonia
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Anti-Bacterial Agents
Antibiotics, Antitubercular
Sulfamethoxazole
Trimethoprim
Trimethoprim-Sulfamethoxazole Combination
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Anti-Infective Agents, Urinary
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 23, 2014