Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00396526
Status:
COMPLETED
Last Update Posted:
2006-12-07
First Post:
2006-11-04
Brief Title:
ICMR-Indiaclen Trial on Amoxycillin vs Cotrimoxazole for Non-Severe Pneumonia
Sponsor:
King Georges Medical University
Organization:
King Georges Medical University
Study Overview
Official Title:
Effectiveness of 3 Day Amoxycillin Versus 5 Day co-Trimoxazole in the Treatment of Non-Severe Pneumonia in Children Aged 2- 59 Months of Age - A Multi-Centric Open Labeled Trial
Status:
COMPLETED
Status Verified Date:
2006-12
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:
Background With documented rise in bacterial resistance in vitro to co-trimoxazole there is a need to document in vivo effectiveness of the drug in treatment of non-severe pneumonia in the community setting
Setting The study will be conducted in 18 rural primary health center PHC in 9 districts in India near Lucknow Nagpur New Delhi Mumbai Chennai Trivandrum Vellore Chandigarh and Bhopal
Design The unit of randomization will be the PHC The recruited children will be followed up on days 4 6 and 13-15 to assess primary and secondary outcome measures
Hypothesis The primary hypothesis is that the clinical failure rate with use of either oral amoxycillin for three days or five days co-trimoxazole is similar
Intervention Oral Co-trimoxazole 8mgkgday trimithoprim twice a day for five days vs oral amoxycillin 20 mgkgday thrice a day for three days
Main objective To compare the proportion of children aged 2 to 59 months presenting with non-severe pneumonia with or without wheeze who do achieve clinical cure on day 6 on treatment with 5 days oral co-trimoxazole and 3 day oral amoxycillin respectively
Main outcomes measures Clinical cure on day 6 clinical failure between day 1-6 clinical relapse between day 7-15
Inclusion criteria Children aged 2-59 months with non-severe pneumonia based on WHO criteria of respiratory rate above the age specific cut-off with or without wheeze accessible to follow up whose guardians give written informed consent
Exclusion criteria Children with severe disease other infectious disease requiring antibiotic treatment documented use of antibiotic for the last 48 hours three or more episodes of wheezing in a year diagnosed asthmatics known immunodeficiency disease acute or chronic organic disease history of hospitalization within last 15 days measles within last one month drug allergy refusal to give consent prior enrollment in the study
Sample size Has been calculated to test the null hypothesis There will be 1100 children in each arm Thus each PHC is required to recruit a minimum of 122 cases within one year
Policy relevance The findings of the study can effect the ARI management policy If the current study proves that three day amoxycillin is clinically as effective as five day co-trimoxazole and with the well documented evidence of rising resistance to co-trimoxazole short course amoxycillin may become the first line treatment for non-severe pneumonia Time line 18 months Pilot in March 2003 enrollments from April 2003 Interim analysis Nov 2003 DMC meet Dec 2003 Data cleaning June 2004 DMC meet July 2004 Manuscript writing Aug2004
Setting The study will be conducted in 18 rural primary health center PHC in 9 districts in India near Lucknow Nagpur New Delhi Mumbai Chennai Trivandrum Vellore Chandigarh and Bhopal
Design The unit of randomization will be the PHC The recruited children will be followed up on days 4 6 and 13-15 to assess primary and secondary outcome measures
Hypothesis The primary hypothesis is that the clinical failure rate with use of either oral amoxycillin for three days or five days co-trimoxazole is similar
Intervention Oral Co-trimoxazole 8mgkgday trimithoprim twice a day for five days vs oral amoxycillin 20 mgkgday thrice a day for three days
Main objective To compare the proportion of children aged 2 to 59 months presenting with non-severe pneumonia with or without wheeze who do achieve clinical cure on day 6 on treatment with 5 days oral co-trimoxazole and 3 day oral amoxycillin respectively
Main outcomes measures Clinical cure on day 6 clinical failure between day 1-6 clinical relapse between day 7-15
Inclusion criteria Children aged 2-59 months with non-severe pneumonia based on WHO criteria of respiratory rate above the age specific cut-off with or without wheeze accessible to follow up whose guardians give written informed consent
Exclusion criteria Children with severe disease other infectious disease requiring antibiotic treatment documented use of antibiotic for the last 48 hours three or more episodes of wheezing in a year diagnosed asthmatics known immunodeficiency disease acute or chronic organic disease history of hospitalization within last 15 days measles within last one month drug allergy refusal to give consent prior enrollment in the study
Sample size Has been calculated to test the null hypothesis There will be 1100 children in each arm Thus each PHC is required to recruit a minimum of 122 cases within one year
Policy relevance The findings of the study can effect the ARI management policy If the current study proves that three day amoxycillin is clinically as effective as five day co-trimoxazole and with the well documented evidence of rising resistance to co-trimoxazole short course amoxycillin may become the first line treatment for non-severe pneumonia Time line 18 months Pilot in March 2003 enrollments from April 2003 Interim analysis Nov 2003 DMC meet Dec 2003 Data cleaning June 2004 DMC meet July 2004 Manuscript writing Aug2004
Detailed Description:
None
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