ICMR-Indiaclen Trial on Amoxycillin vs Cotrimoxazole for Non-Severe Pneumonia
Condition: Non-Severe Pneumonia; Under-Fives; Children
MeSH terms: Pneumonia
Study type: Interventional
Phase: Phase 3

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.
    


Intervention name(s): 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.
Intervention type(s): Drug
Intervention MeSH terms: Amoxicillin; Trimethoprim, Sulfamethoxazole Drug Combination
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nonsevere pneumonia; treatment; underfives; children; Community; India