Simplified Antibiotic Regimens for Outpatient Treatment of Suspected Sepsis in Neonates and Young Infants in Bangladesh
This study is enrolling participants by invitation only.
Sponsor:
Johns Hopkins Bloomberg School of Public Health
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: October 19, 2012
Last verified: October 2012
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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:
Drug Information available for:
Penicillin G procaine
Penicillin G
Penicillin G sodium
Penicillin G potassium
Gentamicin
Gentamicin sulfate
Bicillin C-R
Amoxicillin
Amoxicillin sodium
Penicillin G benzathine
U.S. FDA Resources
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 ]
| Estimated Enrollment: | 2400 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | September 2013 |
| Estimated 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:
|
|
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
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
| 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: | October 19, 2012 |
| 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 Amoxicillin Anti-Bacterial Agents Gentamicins |
Penicillin G Penicillin G Benzathine Penicillin G Procaine Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013