Efficacy Study of Community-Based Treatment of Serious Bacterial Infections in Young Infants

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by Aga Khan University.
Recruitment status was  Active, not recruiting
Information provided by:
Aga Khan University
ClinicalTrials.gov Identifier:
First received: September 12, 2005
Last updated: September 7, 2006
Last verified: September 2006

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.

Condition Intervention Phase
Bacterial Infection
Infant, Newborn
Drug: ceftriaxone, procaine penicillin and gentamicin, oral cotrimoxazole and gentamicin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Aga Khan University:

Primary Outcome Measures:
  • The primary outcome of success rate will be defined as patient cured or improved with the regimen assigned to, on day 7 of therapy.

Secondary Outcome Measures:
  • Completion rates
  • Adverse events
  • Relapse rates

Estimated Enrollment: 426
Study Start Date: November 2003
Estimated Study Completion Date: December 2005

Ages Eligible for Study:   up to 59 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 0-59 days presenting to Young Infant community study site
  • Clinical diagnosis of possible serious bacterial infection by study physician according to specified clinical criteria
  • Parents refuse to accept referral care and sign (or thumb imprint) document stating this.
  • Parents consent to community centre-based intramuscular antibiotic injections

Exclusion Criteria:

  • Age over 59 days
  • Presence of severe jaundice diagnosed clinically or by laboratory investigation (bilirubin > 12 g/dl in term and > 7 in pre-term baby).
  • Presence of obvious meningitis (bulging fontanelle, observed seizures)
  • Patient previously enrolled in antibiotic therapy trial
  • Parents accept hospital referral
  • Parents do not consent to any injectable therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00189384

Aga Khan University community field sites
Karachi, Sindh, Pakistan, 74800
Sponsors and Collaborators
Aga Khan University
Principal Investigator: Anita KM Zaidi, MBBS, SM Department of Pediatrics, Aga Khan University
  More Information

ClinicalTrials.gov Identifier: NCT00189384     History of Changes
Other Study ID Numbers: SC/SNL 11150-0902-50001-269 
Study First Received: September 12, 2005
Last Updated: September 7, 2006
Health Authority: Pakistan:Pakistan Medical Research Council

Keywords provided by Aga Khan University:
Neonatal sepsis
Neonatal pneumonia
Bacterial infections
Young infants
Developing country

Additional relevant MeSH terms:
Bacterial Infections
Communicable Diseases
Penicillin G
Penicillin G Benzathine
Penicillin G Procaine
Trimethoprim, Sulfamethoxazole Drug Combination
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Infective Agents, Urinary
Antiparasitic Agents
Antiprotozoal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Synthesis Inhibitors
Renal Agents

ClinicalTrials.gov processed this record on May 23, 2016