Safety and Pharmacokinetics of Single and Multiple Dose Rifampin in Infants

University of North Carolina (UNC)

Status and phase: Terminated; Phase 1

Conditions: Infection

Treatments: Drug: rifampin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01441206

1K23HD068497-01 (U.S. NIH Grant/Contract)

10-2314

Details and patient eligibility

About

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

Full description

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

Enrollment: 2 patients

Sex: All

Ages: Under 121 days old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

rifampin

Other group

Description:

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

Treatment:

Drug: rifampin

rifampin per standard of care

No Intervention group

Description:

Cohort 2: Receiving rifampin per standard of care