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Safety and Pharmacokinetics of Single and Multiple Dose Rifampin in Infants

NCT01441206 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2012-09-14

No results posted yet for this study

Summary

The purpose of this study is to learn more about the safety and dosing of rifampin in infants.

Conditions

Interventions

DRUG

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

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Matthew M. Laughon, MD, MPH · University of North Carolina, Chapel Hill

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
121 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01441206 on ClinicalTrials.gov