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

Systemic Infection research study

What is the primary objective of this study?

Multiple center, open-label, PK study

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Systemic Infection

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:AntibioticTicarcillin-clavulanate/Timentin is an antibiotic used to treat a wide variety of bacterial infections. Rifampin/Rifadin/Rimatane is an antibiotic and first line antituberculotic. Clindamycin/Cleocin is an antibiotic used to treat a wide variety of bacterial infections and serious bacterial infections.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Ticarcillin-clavulanate antibiotic

Rifampin generic antibiotic

Clindamycin Generic AntibioticCohort GA PNA Dose <30 weeks <14 days 10 mg/kg Q 12 hours x 6 doses <30 weeks ≥14 days-45 days 10 mg/kg Q 8 hours x 6 doses <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.

Study Status

Completed

Start Date: January 2013

Completed Date: May 2015

Phase: Phase 1

Type: Interventional

Design:

Primary Outcome: Pharmacokinetic concentrations in plasma will be measured at a central lab using a validated bioanalytical assay. Plasma samples will be drawn according to specific schedules for each drug

Secondary Outcome: Safety review will be performed through monitoring of adverse events each day that the infant is on study

Study sponsors, principal investigator, and references

Principal Investigator: Philip B Smith, MD

Lead Sponsor: Phillip Brian Smith

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01728363

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