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.
The management of isolated fast breathing is therefore unknown and our experience suggests that these infants could perhaps be managed without antibiotics. Widespread application of the WHO clinical algorithm could therefore result in the referral of as many as 13.7% (135.7 per 1000 live births) of all infants for isolated fast breathing, the vast majority of these unnecessarily, and exposing infants to a high risk of nosocomial sepsis and hospital mortality in addition to over-burdening health resources.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
963
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
It will be given 2 times/day for 7 days
Primary Health Centers
Karachi, Sindh, Pakistan
Treatment failure
1. O2 sat \<90% on Day 2 or any time until Day 7. 2. Clinical deterioration: emergence of any sign of being critically ill or severe infection at any time after randomization (as defined in exclusion criteria) 3. Development of serious adverse effect of the study antibiotics (death, organ failure, anaphylactic reaction, severe diarrhoea, disseminated and severe rash). 4. Hospitalization any time after admission in the study. 5. Death anytime within day 1-7 of enrolment
Time frame: Day 8 of enrollemnt
Compliance to treatment
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.
Time frame: 80% of total dosage
Proportion of infants relapse
Time frame: No treatment failure by day 8 and signs of sepsis or fast breathing between day 8-14
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