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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00189384
Recruitment Status : Unknown
Verified September 2006 by Aga Khan University.
Recruitment status was:  Active, not recruiting
First Posted : September 19, 2005
Last Update Posted : September 11, 2006
Information provided by:
Aga Khan University

Brief 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.

Condition or disease Intervention/treatment Phase
Bacterial Infection Sepsis Infant, Newborn Drug: ceftriaxone, procaine penicillin and gentamicin, oral cotrimoxazole and gentamicin Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 426 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2003
Study Completion Date : December 2005

Primary Outcome Measures :
  1. 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 :
  1. Completion rates
  2. Adverse events
  3. Relapse rates

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 59 Days   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00189384

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

Layout table for additonal information Identifier: NCT00189384     History of Changes
Other Study ID Numbers: SC/SNL 11150-0902-50001-269
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: September 11, 2006
Last Verified: September 2006

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

Additional relevant MeSH terms:
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Communicable Diseases
Bacterial Infections
Systemic Inflammatory Response Syndrome
Pathologic Processes
Trimethoprim, Sulfamethoxazole Drug Combination
Penicillin G Procaine
Penicillin G
Penicillin G Benzathine
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents
Antiprotozoal Agents
Antiparasitic Agents
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents