Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00372541
Status:
COMPLETED
Last Update Posted:
2010-07-26
First Post:
2006-09-06
Brief Title:
Ceftriaxone Versus Chloramphenicol for Treatment of Severe Pneumonia in Children
Sponsor:
Makerere University
Organization:
Makerere University
Study Overview
Official Title:
Ceftriaxone Versus Chloramphenicol for Treatment of Severe Pneumonia in Children Aged Less Than Five Years at Mulago Hospital A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2010-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 927 of children who receive once daily intravenous ceftriaxone 75 mgkg body weightfor 7 days will recover from severe pneumonia compared to 802 of those who receive intravenous chloramphenicol 25mgkg body weightdose every 6 hours for 7 days
We hypothesize that 927 of children who receive once daily intravenous ceftriaxone 75 mgkg body weightfor 7 days will recover from severe pneumonia compared to 802 of those who receive intravenous chloramphenicol 25mgkg body weightdose 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 25mgkg six hourly as the first line drug for the treatment of severe pneumonia in these children Ceftriaxone 75mgkg 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 75mgkgday for seven days or intravenous chloramphenicol 100mgkgday for seven days The primary outcome will mortality and secondary outcomes will be time taken to normalization of respiratory rate temperature and oxygen saturation
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 75mgkgday for seven days or intravenous chloramphenicol 100mgkgday 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None