Simplified Antibiotic Regimens for Outpatient Treatment of Suspected Sepsis in Neonates and Young Infants in Bangladesh

This study has been completed.
Sponsor:
Collaborator:
Dhaka Shishu Hospital
Information provided by (Responsible Party):
Abdullah Baqui, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT00844337
First received: February 13, 2009
Last updated: September 12, 2014
Last verified: September 2014
  Purpose

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. Three 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; (2) injectable penicillin and gentamicin once daily for two days followed by oral amoxicillin twice daily for five days; and (3) injectable gentamicin once daily and oral amoxicillin twice daily for two days followed by oral amoxicillin twice daily for five days.

Hypothesis

The proportion who fails treatment will be 10 percent in the reference group and the alternative treatment groups. An alternative therapy will be considered non-inferior to the standard therapy if the failure rate in the alternative therapy exceeds the failure rate in the injectable therapy by less than 5 absolute percentage points.

Secondary Objectives:

  • To identify baseline clinical predictors of treatment failure in severe infections in young infants.
  • To determine the proportion of relapse (young infants who were considered cured by day 7 but developed any of the signs of suspected severe infection by day 14).

Condition Intervention
Sepsis
Drug: Gentamicin & Amoxicillin x 7days
Drug: Penicillin & gentamicin x 2 d + Amoxicillin X 5 d
Drug: Standard reference therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Simplified Antibiotic Regimens for Outpatient Treatment of Suspected Sepsis in Neonates and Young Infants in Bangladesh

Resource links provided by NLM:


Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • Treatment failure [ Time Frame: Seven days ] [ Designated as safety issue: Yes ]

Enrollment: 2490
Study Start Date: March 2009
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
One study arm will receive injectable gentamicin once daily and oral amoxicillin twice daily for seven days by comparison to other study arms.
Drug: Gentamicin & Amoxicillin x 7days

Injectable gentamicin once daily and oral amoxicillin twice daily for seven days.

The dose for gentamicin is 4 - 5 mg/kg/24 hours. The dose for amoxicillin is 90-115 mg/kg/day.

Other Name: Gentamicin & Amoxicillin
Active Comparator: 2
Injectable penicillin and gentamicin once daily for two days followed by oral amoxicillin twice daily for five days
Drug: Penicillin & gentamicin x 2 d + Amoxicillin X 5 d
Injectable penicillin and gentamicin once daily for two days followed by oral amoxicillin twice daily for five days. The dose for penicillin is 40,000 - 50,000 U/kg/24 hours, the dose for gentamicin is 4 - 5 mg/kg/24 hours, and the dose for amoxicillin is 90-115 mg/kg/day.
Other Names:
  • Penicillin
  • Gentamicin
Active Comparator: 3
Injectable procaine-benzyl penicillin and gentamicin once daily each for seven days (COMPARISON ARM)
Drug: Standard reference therapy
Injectable procaine-benzyl penicillin and gentamicin once daily each for seven days. The penicillin dose is 40,000 - 50,000 U/kg/24 hours, and the gentamicin dose is 4 - 5 mg/kg/24 hours.

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  • Infants 0-59 days old who are residents of catchment population of the study hospitals
  • One or more of the following five signs: severe chest in-drawing, axillary temperature >37.80C or <35.50 C, lethargic or less than normal movement, and history of feeding problems (confirmed by poor suck on feeding assessment)
  • Family refuses recommended hospitalization or hospitalization otherwise not feasible
  • Informed consent by a legal guardian.

Exclusion Criteria:

  • Very severe infection/disease characterized by presence of any of the following signs (unconscious, convulsions, unable to feed, apnea, unable to cry, cyanosis, bulging fontanel, major congenital malformations, major bleeding, surgical conditions needing hospital referral, persistent vomiting defined as vomiting following three attempts to feed the baby within ½ hour, and/or physician's suspicion of meningitis)
  • Very low birth weight: weight <1500
  • Hospitalization for illness in the last two weeks
  • Hospital born infants
  • Previous inclusion in the study
  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: NCT00844337

Locations
Bangladesh
Chittagong Ma O Shishu Hospital
Chittagong, Bangladesh
Shishu Shastya Foundation
Dhaka, Bangladesh
Dhaka Shishu Hospital/CHRF
Dhaka, Bangladesh, 1216
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Dhaka Shishu Hospital
Investigators
Principal Investigator: Abdullah H Baqui, MBBSMPHDrPH Johns Hopkins University Bloomberg School of Public Health
  More Information

No publications provided by Johns Hopkins Bloomberg School of Public Health

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Abdullah Baqui, Professor, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00844337     History of Changes
Other Study ID Numbers: JHU IRB 1440, USAID GHS-A-00-09-00004-00
Study First Received: February 13, 2009
Last Updated: September 12, 2014
Health Authority: United States: Institutional Review Board
Bangladesh: Ethical Review Committee
United Nations: World Health Organization

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
antibiotic regimens
sepsis
young infants
Bangladeshi
outpatient treatment
Suspected sepsis in young infants

Additional relevant MeSH terms:
Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Anti-Bacterial Agents
Amoxicillin
Gentamicins
Penicillin G
Penicillin G Benzathine
Penicillin G Procaine
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014