Safety and Pharmacokinetics of Single and Multiple Dose Rifampin in Infants
NCT ID: NCT01441206
Last Updated: 2012-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
2 participants
INTERVENTIONAL
2011-09-30
2012-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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rifampin
Cohort 1 will include infants who will be receiving up to 4 doses rifampin per study protocol.
rifampin
Infants who will be receiving up to 4 doses of rifampin per protocol(Cohort 1)
Cohort 1:
Dosing will be as follows:
GA at birth \< 32 weeks - PNA \< 14 days: 10 mg/kg QD GA at birth \< 32 weeks - PNA ≥ 14 days: 15 mg/kg QD GA at birth ≥ 32 weeks - PNA \< 14 days: 15 mg/kg QD GA at birth ≥ 32 weeks - PNA ≥ 14 days: 20 mg/kg QD
rifampin per standard of care
Cohort 2: Receiving rifampin per standard of care
No interventions assigned to this group
Interventions
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rifampin
Infants who will be receiving up to 4 doses of rifampin per protocol(Cohort 1)
Cohort 1:
Dosing will be as follows:
GA at birth \< 32 weeks - PNA \< 14 days: 10 mg/kg QD GA at birth \< 32 weeks - PNA ≥ 14 days: 15 mg/kg QD GA at birth ≥ 32 weeks - PNA \< 14 days: 15 mg/kg QD GA at birth ≥ 32 weeks - PNA ≥ 14 days: 20 mg/kg QD
Eligibility Criteria
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Exclusion Criteria
* History of allergic reactions to rifampin
* Aspartate aminotransferase (AST) greater than 3 times upper limit of normal
* Alanine aminotransferase (ALT) greater than 3 times upper limit of normal
* Serum creatinine greater than 1.7 mg.dL
* Urine output \< 0.5 mL/hr/kg over the prior 24 hours
* Any condition which would make the subject, in the opinion of the investigator, unsuitable for the study
Cohort 2:
* None
121 Days
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Matthew M. Laughon, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
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University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Countries
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Other Identifiers
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10-2314
Identifier Type: -
Identifier Source: org_study_id