Pharmacokinetics and Safety of Ticarcillin-clavulanate in Infants

NCT01229046 | Withdrawn Phase 1

• 1 other identifier: Pro00026692
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the safety, tolerability and PK of ticarcillin-clavulanate in infants \<91 days of age with suspected systemic infection.

Conditions

Sepsis

Keywords

presumed sepsis

Outcome Measures

Primary Outcomes (1)

• Clearance of ticarcillin-clavulanate

  The following PK parameters will be estimated: 1. Systemic clearance 2. Volume of distribution 3. Cmax, Tmax, AUC0-Τ, (at steady state), Ke and t1/2 4. CSF/plasma ticarcillin-clavulanate concentration ratio 5. Urine/plasma ticarcillin-clavulanate concentration ratio

  steady state samples will be drawn on day 2-3 of study drug therapy (around dose 4, 5, or 6)

Secondary Outcomes (1)

• Incidence of adverse events as a measure of safety and tolerability

  1st dose to 7 days after the last dose

Study Arms (1)

ticarcillin-clavulanate

ACTIVE COMPARATOR

5 doses of IV ticarcillin-clavulanate infants \< 14 days PNA will receive 75 mg/kg Q12 infants ≥ 14 days PNA will receive 75 mg/kg Q8

Drug: Ticarcillin-clavulanic acid

Interventions

Ticarcillin-clavulanic acid DRUG

5 doses of IV ticarcillin-clavulanate infants \< 14 days PNA will receive 75 mg/kg Q12 infants ≥ 14 days PNA will receive 75 mg/kg Q8

ticarcillin-clavulanate

Eligibility Criteria

• Age: Up to 90 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Written permission from parent or legal guardian
• \< 91 days of age
• \< 30 weeks gestation at birth
• Likely to survive beyond the first 48 hours after enrollment
• Sufficient intravascular access (either peripheral or central) to receive study drug.
• AND ONE OF THE FOLLOWING
• Suspected systemic infection
• Receiving ticarcillin-clavulanate as part of standard of care

You may not qualify if:

• History of allergic reactions to any penicillin, cephalosporins, or beta-lactamase inhibitors
• Urine output \< 0.5 mL/hr/kg over the prior 24 hours
• Serum creatinine \> 1.7 mg/dL
• Any condition which would make the subject, in the opinion of the investigator, unsuitable for the study

Sponsors & Collaborators

• Phillip Brian Smith: lead

Study Sites (1)

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Sepsis

Interventions

ticarcillin-clavulanic acid

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: October 14, 2010
• First Posted: October 27, 2010
• Study Start: September 1, 2010
• Last Updated: November 14, 2012

Record last verified: 2012-11

Locations

US (1)