Community Based Management of Fast Breathing in Infants Aged < 60 Days in Low-income Settlements of Karachi (MAT-YI)
The aim of the study is to determine optimal management of isolated fast breathing in young infants in a trial design conducted in primary care settings.
The investigators hypothesized that proportion of infants who fail therapy will be 4% in each group. A 6% or less difference in failure rate will be considered equivalent.
Fast Breathing in Young Infants
Drug: Sugar Syrup
|Study Design:||Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Community Based Management of Fast Breathing in Infants Aged < 60 Days: A Double-Blind, Randomized Placebo-Controlled Trial in Low-income Settlements of Karachi|
- Treatment failure [ Time Frame: Day 8 of enrollemnt ] [ Designated as safety issue: Yes ]
- O2 sat <90% on Day 2 or any time until Day 7.
- Clinical deterioration: emergence of any sign of being critically ill or severe infection at any time after randomization (as defined in exclusion criteria)
- Development of serious adverse effect of the study antibiotics (death, organ failure, anaphylactic reaction, severe diarrhoea, disseminated and severe rash).
- Hospitalization any time after admission in the study.
- Death anytime within day 1-7 of enrolment
- Compliance to treatment [ Time Frame: 80% of total dosage ] [ Designated as safety issue: Yes ]To label as per protocol infant should receive 100% (4 doses) of doses in first 2 days followed by 70% (7 doses) of doses from day 3 to day 8.
- Proportion of infants relapse [ Time Frame: No treatment failure by day 8 and signs of sepsis or fast breathing between day 8-14 ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2012|
|Study Completion Date:||May 2014|
|Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Amoxicillin
This is an active intervention
80-100 mg/kg/day in 2 divided doses for 7 days
For convenience dose divided into six weight bands Table 2: Dose of amoxicillin Weight band Amount per dose Daily dose Lower Limit (mg or units /kg/d) Upper Limit (mg or units /kg/d) Amoxicillin - desired range 75-100 mg/kg/day (25mg/ml (125mg/5ml); twice daily orally)* 1.8-1.9 kg 3.0 ml 150 mg 75.4 100.0 2.0-2.4 kg 4.0 ml 200 mg 80.3 100.0 2.5-2.9 kg 5.0 ml 250 mg 83.6 100.0 3.0-3.9 kg 6.0 ml 300 mg 75.2 100.0 4.0-4.9 kg 8.0 ml 400 mg 80.2 100.0 5.0-5.9 kg 10.0 ml 500 mg 83.5 100.0
|Placebo Comparator: Sugar Syrup||
Drug: Sugar Syrup
It will be given 2 times/day for 7 days
Please refer to this study by its ClinicalTrials.gov identifier: NCT01533818
|Primary Health Centers|
|Karachi, Sind, Pakistan, 74800|
|Principal Investigator:||Shiyam Sunder P Tikmani, MBBS||Aga Khan University|