Pharmacokinetics of intravenous tigecycline in pediatric patients

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

TCTR

Registry ID

TCTR20240319006

Enrollment

Registered

2024-03-19

Start date

2024-05-29

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PK parameters of tigecycline in pediatric patients with multidrug-resistant infection receiving intravenous tigecycline Tigecycline, Pharmacokinetics, Multidrug-resistant resistant organisms, Pediatrics

Interventions

Patients aged 1 month to 8 years were prescribed intravenous tigecycline infusion prescribed by their primary physicians for treating MDRO infection.

Treatment

Pediatric patients

Eligibility

Sex/Gender

All

Age

1 Months to 8 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 1 month to 8 years on the day of enrollment 2. Receiving intravenous tigecycline at least 6 doses prescribed by their primary physicians for treating MDROs infection 3. Adequate vascular access to enable blood collection

Exclusion criteria

Exclusion criteria: 1. Body weight of less than 3 kg 2. Tetracycline or tigecycline allergy 3.Patients with a Child-Pugh Score class C, which requires an adjustment to the tigecycline dosage

Design outcomes

Primary

Measure	Time frame
steady-state PK parameters At predose, immediately after the end of infusion, and then approximately 1, 2, 4, 6, 8, and 12 (before the next dose given) h after the start of tigecycline administration High-performance liquid chromatography method,Appropriate dose of intravenous tigecycline At steady-state PK parameters at least 6 doses of tigecycline intravenous infusion PK-PD target achievement evaluation	—

Measure

Time frame

steady-state PK parameters At predose, immediately after the end of infusion, and then approximately 1, 2, 4, 6, 8, and 12 (before the next dose given) h after the start of tigecycline administration High-performance liquid chromatography method,Appropriate dose of intravenous tigecycline At steady-state PK parameters at least 6 doses of tigecycline intravenous infusion PK-PD target achievement evaluation

—

Secondary

Measure	Time frame
Proportions of patients achieving the desired PK-PD index will be reported as counts with percentages. At steady-state PK parameters at least 6 doses of tigecycline intravenous infusion Numbers and percentages by a simple calculation,Treatment outcomes 30 days 30-day mortality rate,Microbiological outcomes 48-72 hours after receiving tigecycline intravenous infusion Eradication, Persistence	—

Countries

Thailand

Contacts

Public ContactNarut Suphap

Faculty of Medicine, Chulalongkorn University

Narut.S@chula.ac.th6622564930

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026