Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00189384
Status:
UNKNOWN
Last Update Posted:
2006-09-11
First Post:
2005-09-12
Brief Title:
Efficacy Study of Community-Based Treatment of Serious Bacterial Infections in Young Infants
Sponsor:
Aga Khan University
Organization:
Aga Khan University
Study Overview
Official Title:
Randomized Controlled Trial of Intramuscular Ceftriaxone Versus Procaine Penicillin Versus Cotrimoxazole and Gentamicin for Management of Serious Bacterial Infections in Young Infants in Community Settings
Status:
UNKNOWN
Status Verified Date:
2006-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Approximately one-third of neonatal deaths in developing countries are due to infections acquired through the birth canal andor 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 aminoglycosideHowever 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 communityfirst-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
Thus there is an urgent need to define the role of communityfirst-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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None