Safety and Pharmacokinetics of Single and Multiple Dose Rifampin in Infants

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01441206

Enrollment

Registered

2011-09-27

Start date

2011-09-30

Completion date

2012-04-30

Last updated

2012-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection

Keywords

rifampin, infants

Brief summary

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

Detailed description

Pharmacokinetics and safety of rifampin will be studied in term and preterm infants who are receiving rifampin per standard of care.

Interventions

DRUGrifampin

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 121 Days

Healthy volunteers

Inclusion criteria

Cohort 1: * Suspected systemic infection * Infant \< 121 days of age at the time of 1st dose of rifampin administration * Sufficient intravascular access (either peripheral or central) to receive rifampin. Cohort 2: * Receiving rifampin per local standard of care. * Infant \< 121 days of age at the time of 1st dose of rifampin administration

Exclusion criteria

Cohort 1: * 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

Design outcomes

Primary

Measure	Time frame
Area under the plasma concentration versus time curve 0-24 hours for rifampin	Sampling for 24 hr dosing:Dose 1:0-15min,30-60min,1-3hr,3-6hr, 6-12hr,12-18hr. Dose 2,3 or 4:<15min prior to dose, 48-72hrs. Sampling for 12 hr dosing:Dose 1: 0-15min, 0.5-1hr, 1-2hr, 2-4hr, 5-8hr, 8-10 hr. Dose 2, 3 or 4:<15min prior to dose, 24-36hr
Peak plasma concentration of rifampin	Sampling for 24 hr dosing:Dose 1:0-15min,30-60min,1-3hr,3-6hr, 6-12hr,12-18hr. Dose 2,3 or 4:<15min prior to dose, 48-72hrs. Sampling for 12 hr dosing:Dose 1: 0-15min, 0.5-1hr, 1-2hr, 2-4hr, 5-8hr, 8-10 hr. Dose 2, 3 or 4:<15min prior to dose, 24-36hr
Clearance of rifampin	Sampling for 24 hr dosing:Dose 1:0-15min,30-60min,1-3hr,3-6hr, 6-12hr,12-18hr. Dose 2,3 or 4:<15min prior to dose, 48-72hrs. Sampling for 12 hr dosing:Dose 1: 0-15min, 0.5-1hr, 1-2hr, 2-4hr, 5-8hr, 8-10 hr. Dose 2, 3 or 4:<15min prior to dose, 24-36hr
Volume of distribution at steady state	Sampling for 24 hr dosing:Dose 1:0-15min,30-60min,1-3hr,3-6hr, 6-12hr,12-18hr. Dose 2,3 or 4:<15min prior to dose, 48-72hrs. Sampling for 12 hr dosing:Dose 1: 0-15min, 0.5-1hr, 1-2hr, 2-4hr, 5-8hr, 8-10 hr. Dose 2, 3 or 4:<15min prior to dose, 24-36hr
Half life of rifampin	Sampling for 24 hr dosing:Dose 1:0-15min,30-60min,1-3hr,3-6hr, 6-12hr,12-18hr. Dose 2,3 or 4:<15min prior to dose, 48-72hrs. Sampling for 12 hr dosing:Dose 1: 0-15min, 0.5-1hr, 1-2hr, 2-4hr, 5-8hr, 8-10 hr. Dose 2, 3 or 4:<15min prior to dose, 24-36hr

Secondary

Measure	Time frame
Number of subjects with adverse events as a measure of safety and tolerability.	From the time of the first dose to 3 days after the last dose; serious adverse events will be collected from the first dose of rifampin to 7 days after the last dose of rifampin.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026