Pharmacokinetics (PK) of Antistaphylococcal Antibiotics in Infants (NICHD-2012-02-Staph Trio)

Phillip Brian Smith

Status and phase: Completed; Phase 1

Conditions: Systemic Infection

Treatments: Drug: Antibiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT01728363

Pro00037820

Details and patient eligibility

About

Multiple center, open-label, PK study

Full description

Pharmacokinetics of rifampin, ticarcillin-clavulanate, and clindamycin antibiotics in hospitalized infants with suspected systemic infection or receiving one of the study drugs per local standard of care. Number of participants are 16-32 evaluable per each study drug of rifampin, ticarcillin-clavulanate, and clindamycin antibiotics.

Enrollment: 63 patients

Sex: All

Ages: 14 days to 32 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Sufficient intravascular access
• Suspected systemic infection or receiving 1 of the study drugs per standard of care
• informed consent from legal guardian

Exclusion criteria

• history of allergic reaction to study drugs
• urine output <0.5 mL/hr/kg over the prior 24 hours
• serum creatinine >1.7 mg/dl
• Any condition in investigator judgment precludes participation because it could affect participant safety

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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63 participants in 3 patient groups

Ticarcillin-clavulanate antibiotic

Experimental group

Description:

Cohort Gestational Age (GA) Postnatal Age (PNA) Dose 1. \<30 weeks \<14 days: 75 mg/kg Q12 hrs x 6 doses 2. \<30 weeks ≥14 days-45 days 75 mg/kg Q 8 hours x 6 doses 3. \<30 weeks \>45 days-90 days 75 mg/kg Q 6 hours x 6 doses Brand name is Timentin. This drug is an antibiotic used to treat a wide variety of bacterial infections. It is a combination of two drugs \& both treat bacterial infections. Ticarcillin is a penicillin-type antibiotic that stops bacterial growth \& clavulanate potassium is an enzyme inhibitor that helps the ticarcillin work better.

Treatment:

Drug: Antibiotic

Rifampin generic antibiotic

Experimental group

Description:

Cohort GA PNA Dose 1. \<32 weeks \<14 days 10 mg/kg Q 24 hours x 4 doses 2. \<32 weeks ≥14 days-120 days 15 mg/kg Q 24 hours x 4 doses 3. ≥32 weeks \<14 days 15 mg/kg Q 24 hours x 4 doses 4. ≥32 weeks ≥14 days-120 days 20 mg/kg Q 24 hours x 4 doses The brand name is Rifadin, Rimatane. This drug is an antibiotic and a first line antituberculotic and unlabeled use for infections caused by staphylococcus aureus \& staphylococcus epidermis.

Treatment:

Drug: Antibiotic

Clindamycin Generic Antibiotic

Experimental group

Description:

Cohort GA PNA Dose 1. \<30 weeks \<14 days 10 mg/kg Q 12 hours x 6 doses 2. \<30 weeks ≥14 days-45 days 10 mg/kg Q 8 hours x 6 doses 3. \<30 weeks \>45 days-120 days 10 mg/kg Q 6 hours x 6 doses The brand name is Cleocin. This drug is an antibiotic used to treat a wide variety of bacterial infections and serious infections.

Treatment:

Drug: Antibiotic