ICMR-Indiaclen Trial on Amoxycillin vs Cotrimoxazole for Non-Severe Pneumonia

Children Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00396526
• Other study ID #: 9999
• Status: Completed
• Phase: Phase 3
• First received: November 4, 2006
• Last updated: December 5, 2006
• Start date: April 2004
• Est. completion date: April 2006

Study information

• Verified date: December 2006
• Source: King George's Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review BoardIndia: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial 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 (8mg/kg/day trimithoprim) twice a day for five days vs. oral amoxycillin (20 mg/kg/day) 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 Aug.2004.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Months to 59 Months

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Children
• Non-Severe Pneumonia
• Pneumonia
• Under-Fives

Intervention

Drug:
• Oral Co-trimoxazole (8mg/kg/day trimithoprim) twice a day for five days vs. oral amoxycillin (20 mg/kg/day) thrice a day for three days.

Locations

Country	Name	City	State
India	Dr. Shally Awasthi	Lucknow	Uttar Pradesh

Sponsors (3)

Lead Sponsor	Collaborator
King George's Medical University	Indian Council of Medical Research, United States Agency for International Development (USAID)

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcome:
Primary	Clinical Cure: Respiratory rate below age specific cut-off (<50 bpm in infants <12 months and <40 bpm in 12 – 59 months of age).
Secondary	Clinical failure: Clinical deterioration as indicated by the occurrence of one or more of the following at any time in first 6 days:
Secondary	Any signs of severe pneumonia or severe disease: chest in drawing, convulsions, drowsiness or inability to drink at any time.
Secondary	Respiratory rate above age specific cut-off on day 4 or after that
Secondary	Documented axillary temperature > 101 degrees Fahrenheit