Post-Measles PneumoniaPhase 3NCT00168532
Prophylactic Antibiotics in Measles
A Phase 3 study testing Sulfamethoxazole-Trimethoprim in people with Post-Measles Pneumonia and Measles, run by Bandim Health Project at 1 site in Guinea-Bissau.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 months and older
- Conditions the study is for
- Post-Measles Pneumonia, Measles
- What is being tested?
- Sulfamethoxazole-Trimethoprim
- How many people
- 218 participants
- Where
- 1 siteGuinea-Bissau
- Study dates
- Jan 1998to Oct 2001
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- A clinical diagnosis of probable measles in the prodromal phase or within the first seven days of the onset of the rash
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Guinea-Bissau1 site
Bandim Health Project
Bissau, Apartado 861, 1004 Bissau Codex
About this study
Official title: 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.
Read the 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.
- Conditions
- Post-Measles Pneumonia, Measles
- Being tested
- Sulfamethoxazole-Trimethoprim
- Keywords
- Prophylactic antibiotics, Measles, Pneumonia, Post-measles pneumonia, Low income country, Guinea-Bissau, Bandim Health Project
- Medical subject headings
- Measles, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulfamethoxazole-TrimethoprimDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-measles pneumonia
Admission to hospital
Secondary outcomes (7)
Weight gain or loss during the first month of infection
Diarrhoea
Severe fever
Oral thrush
Stomatitis
Conjunctivitis
Otitis media
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJan 1998
- Primary completionOct 2001
- Study completionOct 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-Measles PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 218 participants
Sponsor and investigators
- Lead sponsor
- Bandim Health Project
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council Unit, The Gambia
- Investigators
- PETER AABY, MSc, Dr Med, Study director, Bandim Health ProjectMAY-LILL GARLY, PHD, DTM&H, Principal investigator, Bandim Health Project
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00168532
- Sponsor's protocol ID
- ProfAnt-BHP-1996
- Status last verified
- Feb 2008
- First submitted
- 9 Sep 2005
- Last updated
- 26 Feb 2008
- Results posted
- No
Publications
Garly ML, Bale C, Martins CL, Whittle HC, Nielsen J, Lisse IM, Aaby P. Prophylactic antibiotics to prevent pneumonia and other complications after measles: community based randomised double blind placebo controlled trial in Guinea-Bissau. BMJ. 2006 Dec 16;333(7581):1245. doi: 10.1136/bmj.38989.684178.AE. Epub 2006 Oct 23.
PubMed 17060336
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Antibiotics in Measles Infection. A Community-Based Randomised Double-Blind Placebo-Controlled Trial in Guinea-Bissau
- ClinicalTrials.gov ID
- NCT00168532
- Acronym / sponsor ID
- ProfAnt-BHP-1996
- Conditions
- Post-Measles Pneumonia, Measles
- Keywords
- Prophylactic antibiotics, Measles, Pneumonia, Post-measles pneumonia, Low income country, Guinea-Bissau, Bandim Health Project
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants
- Lead sponsor
- Bandim Health ProjectUniversity, hospital or other
- Collaborators
- Medical Research Council Unit, The Gambia
- Study start
- Jan 1998
- Primary completion
- Oct 2001 (actual)
- Study completion
- Oct 2001 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 3 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- A clinical diagnosis of probable measles in the prodromal phase or within the first seven days of the onset of the rash
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sulfamethoxazole-Trimethoprim | Drug | – |
Primary outcome
Post-measles pneumonia
Admission to hospital
7 secondary outcomes
Weight gain or loss during the first month of infection
Diarrhoea
Severe fever
Oral thrush
Stomatitis
Conjunctivitis
Otitis media
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2008.
- Derived from this study: PubMed 17060336Garly ML, Bale C, Martins CL, Whittle HC, Nielsen J, Lisse IM, Aaby P. Prophylactic antibiotics to prevent pneumonia and other complications after measles: community based randomised double blind placebo controlled trial in Guinea-Bissau. BMJ. 2006 Dec 16;333(7581):1245. doi: 10.1136/bmj.38989.684178.AE. Epub 2006 Oct 23.
- Related InfoLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
PETER AABY, MSc, Dr Med study director
Bandim Health Project
MAY-LILL GARLY, PHD, DTM&H principal investigator
Bandim Health Project
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sulfamethoxazole-Trimethoprim in people with Post-Measles Pneumonia and Measles, run by Bandim Health Project at 1 site in Guinea-Bissau.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guinea-Bissau. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-measles pneumonia. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00168532, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2008.