Efficacy Study of Community-Based Treatment of Serious Bacterial Infections in Young Infants
Status:
Unknown status
Trial end date:
2005-12-01
Target enrollment:
Participant gender:
Summary
Approximately one-third of neonatal deaths in developing countries are due to infections
acquired through the birth canal and/or exposure to an unclean environment soon after birth.
Current World Health Organization recommendations for the management of infants younger than
2 months of age who have serious bacterial infections involve hospitalization and parenteral
therapy for at least 10 days with antibiotic regimens containing penicillin or ampicillin
combined with an aminoglycoside.However, in many settings throughout the developing world,
this is not currently possible, nor is this standard of care likely to be feasible in the
near future. Several studies have reported that for a variety of sociocultural reasons many
families are unable or unwilling to access hospital-based care and their sick young infants
do not get hospitalized, and instead, receive a variety of home-based antibiotic therapies,
or none at all. In our community field sites, approximately 70% of families refuse hospital
referral for a sick newborn, despite provision of transport.
Thus, there is an urgent need to define the role of community/first-level facility-based care
versus hospitalization for the management of young infants with serious bacterial infections,
and the potential for community-based parenteral antibiotics as an alternative strategy in
resource poor areas with high neonatal mortality rates. Bang and colleagues have demonstrated
significant reductions in neonatal mortality from infections in an underdeveloped rural
district in Maharashtra, India by a field-based case management approach which used oral
cotrimoxazole and intramuscular gentamicin given for 7 days as treatment for neonates with
sepsis.
This study is an equivalence randomized controlled trial (RCT) comparing once daily IM
ceftriaxone injection to once daily IM procaine penicillin and gentamicin injection, to once
daily intramuscular gentamicin injection and twice daily oral cotrimoxazole, given for 7 days
in babies with clinically-diagnosed possible serious bacterial infection (pneumonia, or
sepsis with or without local infections such as skin or umbilical infections) whose families
refused referral to a hospital. After supplementary informed consent, patients meeting
specific inclusion and exclusion criteria are randomly allocated to one of the three regimens
being tested. The study hypothesis is that all 3 regimens will perform equally well in the
treatment of sepsis in a first-level facility setting.
Phase:
Phase 3
Details
Lead Sponsor:
Aga Khan University
Treatments:
Ceftriaxone Gentamicins Penicillin G Penicillin G Benzathine Penicillin G Procaine Penicillins Procaine Trimethoprim, Sulfamethoxazole Drug Combination