PneumoniaPhase 3NCT00372541
Ceftriaxone Versus Chloramphenicol for Treatment of Severe Pneumonia in Children
A Phase 3 study testing ceftriaxone in people with Pneumonia, run by Makerere University at 4 sites in Uganda.
Trial summary
Acute lower respiratory tract infections are a leading cause of morbidity and mortality in sub Saharan Africa. The World Health Organisation (WHO) still recommends intravenous chloramphenicol for the treatment of severe pneumonia in children aged less than five years. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Pneumonia
- What is being tested?
- ceftriaxone
- How many people
- 348 participants
- Where
- 4 sitesUganda
- Study dates
- Sep 2006to Mar 2007
- 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 6 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 6 months to 59months with cough, difficult breathing and lower chest indrawing
- Consent from parent/carer
Who cannot join
- Children with severe Asthmatic attack
- Allergy to any of the study drugs
- Diagnosis of Pneumocystis JiroveciPneumonia on therapeutic treatment
Trial locations and contacts
4 sites in 1 country.
Uganda4 sites
Department of Paediatrics and Child Health, Mulago Hospital
Kampala, East Africa, 256
Department of Paediatrics and Child Health, Makerere University
Kampala, Kampala, P O 7072
Department of paediatrics and child Health,Makerere university
Kampala, Kampala, P O 7072
Department of Paediatrics and Child, Makerere University
Kampala, Kampala, P O 7072
About this study
Official title: Ceftriaxone Versus Chloramphenicol for Treatment of Severe Pneumonia in Children Aged Less Than Five Years at Mulago Hospital: A Randomized Controlled Trial
Acute lower respiratory tract infections are a leading cause of morbidity and mortality in sub Saharan Africa. The World Health Organisation (WHO) still recommends intravenous chloramphenicol for the treatment of severe pneumonia in children aged less than five years. However, up to 20% of children fail treatment due to the emergence of resistance by bacteria. Several centers now use ceftriaxone, a third generation cephalosporin, which is reported to be efficacious in the treatment of severe pneumonia. However the high cost of ceftriaxone is too prohibitive to allow for its routine use in resource constrained countries. The purpose of this study is to compare chloramphenicol and ceftriaxone in the treatment of severe pneumonia in children under five.
We hypothesize that 92.7% of children who receive once daily intravenous ceftriaxone (75 mg/kg body weight)for 7 days, will recover from severe pneumonia compared to 80.2 % of those who receive intravenous chloramphenicol (25mg/kg body weight/dose every 6 hours for 7 days).
Read the detailed description
A recent report from the World health Organization showed pneumonia was the leading cause of death in children less than 5 years. WHO recommends intravenous Chloramphenicol 25mg/kg six hourly as the first line drug for the treatment of severe pneumonia in these children. Ceftriaxone 75mg/kg daily is the second line drug.
The efficacy of chloramphenicol for the treatment of severe pneumonia ranges from 80%-84%, while that of ceftriaxone ranges from 85% to 97%. However the high cost of ceftriaxone is too prohibitive to allow for its routine use in resource constrained countries. A study comparing penicillin G plus chloramphenicol and ceftriaxone in the treatment of severe pneumonia in Turkey found that both drugs were equally effective in normalization of the outcome parameters. A recent Cochrane review found no randomized controlled trials comparing both drugs in the treatment of severe forms of pneumonia.
The objective of this study it to compare the efficacy of Ceftriaxone versus Chloramphenicol in the treatment of severe pneumonia in the children under five years of age admitted to Mulago hospital.
This will be a double- blinded randomized controlled trial. Three hundred forty eight children with severe pneumonia will be randomized to receive either intravenous ceftriaxone 75mg/kg/day for seven days or intravenous chloramphenicol 100mg/kg/day for seven days. The primary outcome will mortality and secondary outcomes will be time taken to normalization of respiratory rate, temperature and oxygen saturation.
- Conditions
- Pneumonia
- Being tested
- ceftriaxone
- Keywords
- ceftriaxone, chloramphenicol, severe pneumonia, children
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ceftriaxoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality from severe pneumonia by 7th day of treatment
Secondary outcomes (3)
Time to normalisation of respiratory rate
Time to normalisation temperature
Time to normalisation of oxygen saturation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for 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
- 348 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Investigators
- Cordelia M Katureebe, MBCHB, Principal investigator, Makerere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00372541
- Sponsor's protocol ID
- HD1120041348U
- Status last verified
- Jul 2010
- First submitted
- 6 Sep 2006
- Last updated
- 26 Jul 2010
- Results posted
- No
Publications
Cetinkaya F, Gogremis A, Kutluk G. Comparison of two antibiotic regimens in the empirical treatment of severe childhood pneumonia. Indian J Pediatr. 2004 Nov;71(11):969-72. doi: 10.1007/BF02828108.
PubMed 15572814Bakeera-Kitaka S, Musoke P, Downing R, Tumwine JK. Pneumocystis carinii in children with severe pneumonia at Mulago Hospital, Uganda. Ann Trop Paediatr. 2004 Sep;24(3):227-35. doi: 10.1179/027249304225019046.
PubMed 15479572Bjerre LM, Verheij TJ, Kochen MM. Antibiotics for community acquired pneumonia in adult outpatients. Cochrane Database Syst Rev. 2004;(2):CD002109. doi: 10.1002/14651858.CD002109.pub2.
PubMed 15106168Ortiz-Ruiz G, Vetter N, Isaacs R, Carides A, Woods GL, Friedland I. Ertapenem versus ceftriaxone for the treatment of community-acquired pneumonia in adults: combined analysis of two multicentre randomized, double-blind studies. J Antimicrob Chemother. 2004 Jun;53 Suppl 2:ii59-66. doi: 10.1093/jac/dkh207.
PubMed 15150184
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ceftriaxone Versus Chloramphenicol for Treatment of Severe Pneumonia in Children Aged Less Than Five Years at Mulago Hospital: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00372541
- Acronym / sponsor ID
- HD1120041348U
- Conditions
- Pneumonia
- Keywords
- ceftriaxone, chloramphenicol, severe pneumonia, children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 348 participants (estimated)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 7 Sep 2006 (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.
Acute lower respiratory tract infections are a leading cause of morbidity and mortality in sub Saharan Africa. The World Health Organisation (WHO) still recommends intravenous chloramphenicol for the treatment of severe pneumonia in children aged less than five years. However, up to 20% of children fail treatment due to the emergence of resistance by bacteria. Several centers now use ceftriaxone, a third generation cephalosporin, which is reported to be efficacious in the treatment of severe pneumonia. However the high cost of ceftriaxone is too prohibitive to allow for its routine use in resource constrained countries. The purpose of this study is to compare chloramphenicol and ceftriaxone in the treatment of severe pneumonia in children under five.
We hypothesize that 92.7% of children who receive once daily intravenous ceftriaxone (75 mg/kg body weight)for 7 days, will recover from severe pneumonia compared to 80.2 % of those who receive intravenous chloramphenicol (25mg/kg body weight/dose every 6 hours for 7 days).
Detailed description
A recent report from the World health Organization showed pneumonia was the leading cause of death in children less than 5 years. WHO recommends intravenous Chloramphenicol 25mg/kg six hourly as the first line drug for the treatment of severe pneumonia in these children. Ceftriaxone 75mg/kg daily is the second line drug.
The efficacy of chloramphenicol for the treatment of severe pneumonia ranges from 80%-84%, while that of ceftriaxone ranges from 85% to 97%. However the high cost of ceftriaxone is too prohibitive to allow for its routine use in resource constrained countries. A study comparing penicillin G plus chloramphenicol and ceftriaxone in the treatment of severe pneumonia in Turkey found that both drugs were equally effective in normalization of the outcome parameters. A recent Cochrane review found no randomized controlled trials comparing both drugs in the treatment of severe forms of pneumonia.
The objective of this study it to compare the efficacy of Ceftriaxone versus Chloramphenicol in the treatment of severe pneumonia in the children under five years of age admitted to Mulago hospital.
This will be a double- blinded randomized controlled trial. Three hundred forty eight children with severe pneumonia will be randomized to receive either intravenous ceftriaxone 75mg/kg/day for seven days or intravenous chloramphenicol 100mg/kg/day for seven days. The primary outcome will mortality and secondary outcomes will be time taken to normalization of respiratory rate, temperature and oxygen saturation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children aged 6 months to 59months with cough, difficult breathing and lower chest indrawing
- Consent from parent/carer
Key exclusion criteria (3 listed)
- Children with severe Asthmatic attack
- Allergy to any of the study drugs
- Diagnosis of Pneumocystis JiroveciPneumonia on therapeutic 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 |
|---|---|---|
| ceftriaxone | Drug | – |
Primary outcome
Mortality from severe pneumonia by 7th day of treatment
3 secondary outcomes
Time to normalisation of respiratory rate
Time to normalisation temperature
Time to normalisation of oxygen saturation
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 Jul 2010.
- Background: PubMed 15572814Cetinkaya F, Gogremis A, Kutluk G. Comparison of two antibiotic regimens in the empirical treatment of severe childhood pneumonia. Indian J Pediatr. 2004 Nov;71(11):969-72. doi: 10.1007/BF02828108.
- Background: PubMed 15479572Bakeera-Kitaka S, Musoke P, Downing R, Tumwine JK. Pneumocystis carinii in children with severe pneumonia at Mulago Hospital, Uganda. Ann Trop Paediatr. 2004 Sep;24(3):227-35. doi: 10.1179/027249304225019046.
- Background: PubMed 15106168Bjerre LM, Verheij TJ, Kochen MM. Antibiotics for community acquired pneumonia in adult outpatients. Cochrane Database Syst Rev. 2004;(2):CD002109. doi: 10.1002/14651858.CD002109.pub2.
- Background: PubMed 15150184Ortiz-Ruiz G, Vetter N, Isaacs R, Carides A, Woods GL, Friedland I. Ertapenem versus ceftriaxone for the treatment of community-acquired pneumonia in adults: combined analysis of two multicentre randomized, double-blind studies. J Antimicrob Chemother. 2004 Jun;53 Suppl 2:ii59-66. doi: 10.1093/jac/dkh207.
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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.
Cordelia M Katureebe, MBCHB principal investigator
Makerere University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ceftriaxone in people with Pneumonia, run by Makerere University at 4 sites in Uganda.
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 2 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 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Uganda. 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?
Mortality from severe pneumonia by 7th day of treatment. 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 NCT00372541, which also lists 4 linked publications.
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 Jul 2010.