Simplified Antibiotic Regimens for Outpatient Treatment of Suspected Sepsis in Neonates and Young Infants in Bangladesh
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|ClinicalTrials.gov Identifier: NCT00844337|
Recruitment Status : Completed
First Posted : February 16, 2009
Last Update Posted : September 16, 2014
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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.
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.
- 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 or disease||Intervention/treatment||Phase|
|Sepsis||Drug: Gentamicin & Amoxicillin x 7days Drug: Penicillin & gentamicin x 2 d + Amoxicillin X 5 d Drug: Standard reference therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2490 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy of Simplified Antibiotic Regimens for Outpatient Treatment of Suspected Sepsis in Neonates and Young Infants in Bangladesh|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||September 2013|
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.
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.
- Treatment failure [ Time Frame: Seven days ]
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|Ages Eligible for Study:||up to 59 Days (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT00844337
|Chittagong Ma O Shishu Hospital|
|Dhaka Shishu Hospital/CHRF|
|Dhaka, Bangladesh, 1216|
|Shishu Shastya Foundation|
|Principal Investigator:||Abdullah H Baqui, MBBSMPHDrPH||Johns Hopkins University Bloomberg School of Public Health|
|Responsible Party:||Abdullah Baqui, Professor, Johns Hopkins Bloomberg School of Public Health|
|Other Study ID Numbers:||
JHU IRB 1440
USAID GHS-A-00-09-00004-00 ( Other Grant/Funding Number: USAID 106744 )
|First Posted:||February 16, 2009 Key Record Dates|
|Last Update Posted:||September 16, 2014|
|Last Verified:||September 2014|
Suspected sepsis in young infants
Systemic Inflammatory Response Syndrome
Protein Synthesis Inhibitors
Molecular Mechanisms of Pharmacological Action