NCT01441206

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2011

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

September 19, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 27, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

September 14, 2012

Status Verified

September 1, 2012

Enrollment Period

7 months

First QC Date

September 19, 2011

Last Update Submit

September 13, 2012

Conditions

Infection

Keywords

rifampininfants

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (1)

  • 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.

Study Arms (2)

rifampin

OTHER

Cohort 1 will include infants who will be receiving up to 4 doses rifampin per study protocol.

Drug: rifampin

rifampin per standard of care

NO INTERVENTION

Cohort 2: Receiving rifampin per standard of care

Interventions

rifampinDRUG

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

Eligibility Criteria

AgeUp to 121 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599-7596, United States

Location

MeSH Terms

Conditions

Infections

Interventions

Rifampin

Intervention Hierarchy (Ancestors)

RifamycinsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsLactams, MacrocyclicMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • Matthew M. Laughon, MD, MPH

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2011

First Posted

September 27, 2011

Study Start

September 1, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

September 14, 2012

Record last verified: 2012-09

Locations

US(1)