The primary aim is to establish the non-inferiority of several simplified, home-based antibiotic regimens compared to the standard course of parenteral antibiotics for the empiric treatment of suspected sepsis in Bangladeshi young infants whose parents refuse hospitalization. Two alternative regimens will be compared with a standard (reference) regimen of injectable procaine-benzyl penicillin and gentamicin once daily each for seven days.
Alternative regimens are (1) injectable gentamicin once daily and oral amoxicillin twice daily for seven days; and, (2) injectable penicillin and gentamicin once daily for two days followed by oral amoxicillin twice daily for five days.
Eligible young infants with suspected sepsis whose parents refuse hospitalization will be recruited from the outpatient departments of the study hospitals and randomized to one of the three regimens. All enrolled infants will receive the first doses of the assigned antibiotics and will be sent home. Treatment will be delivered daily at home by study physicians. In addition, all infants will be assessed daily for the first 8 days (days 1-8), day 11 and day 15 by study physicians through home visits to determine treatment failure. We will evaluate the non-inferiority of the alternative regimens by comparing their treatment failure rates with that of the standard therapy. The proportion of infants failing treatment within 7 days of randomization will be estimated for each group. The difference in these rates (experimental – standard) will be calculated and a 95% confidence interval estimated to determine if the upper bound of this interval exceeds 5%. The difference will be expressed as a ratio of the rate in alternative therapies to failure rate in standard therapy and adjusted in multivariate binomial regression models with a log link, to take into account any differences between the groups in baseline or other potentially confounding variables. An independent Data Safety Monitoring Board (DSMB) consisting of a pediatrician, a clinical trialist, and a biostatistician will be established for this trial. This committee will meet once a year and will be responsible for the monitoring and review of the safety and conduct of the trial.
Summary of study outcome:
In Sylhet, Projahnmo site SATT study started on 15th October’ 2011 and successfully ended on 30th June’2013. We have included two upazilla (Kanaighat & Zakiganj) for our study area. During this period of time we completed screening 6368 children of 0-59 day’s babies.
Among 6368 children’s 696 babies were eligible according to inclusion criteria for enrollment. A total of 506 babies were enrolled in the study. Among 506 cases, 134 cases were (0-6) age group and 372 cases were from (7-59) age group. Total Treatment failures are 55 babies. Out of 55 cases, 18 cases were from (0-6) age group & 37 cases were from (7-59) age group. Total Death cases are 15 babies. Out of 15 cases, 06 cases were from (0-6) age group & 09 cases were from (7-59) age group. Total Relapse cases are 13 babies. Out of 13 cases, 04 cases were from (0-6) age group & 09 cases were from (7-59) age group. Total Consent withdrawn cases are 08 babies. Out of 08 cases, 01 case was from (0-6) age group & 07 cases were from (7-59) age group.