Evaluation of Pharmacokinetics, Safety, and Tolerability of Ceftazidime-avibactam in Neonates and Infants.

PHASE2TerminatedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

January 14, 2020

Primary Completion Date

December 30, 2022

Study Completion Date

December 30, 2022

Conditions
Gram-negative Bacterial Infection
Interventions
DRUG

Part A: Single Dose Ceftazidime-Avibactam, Cohorts 1-3

Single intravenous infusion of ceftazidime-avibactam over 2 hours

DRUG

Part B: Multiple-dose Ceftazidime-Avibactam, Cohorts 1-3

Multiple intravenous infusions of ceftazidime-avibactam over 2 hours, repeated every 8 hours up to 14 days

Trial Locations (18)

300

Hsinchu Mackay Memorial Hospital, Department of Pharmacy, Hsinchu

4032

Debreceni Egyetem Klinikai Központ, Debrecen

4400

Szabolcs-Szatmár-Bereg Megyei Kórházak és Oktatókórház, Jósa András Oktatókórház, Nyíregyháza

8800

Kanizsai Dorottya Korhaz, Nagykanizsa

10041

National Taiwan University Hospital, Taipei

13419

Tallinn Children's Hospital, Tallinn

27710

Duke University Investigational Drug Services, Durham

Duke University Medical Center, Durham

30071

Hsinchu Mackay Memorial Hospital, Hsinchu

84108

University of Utah, Salt Lake City

84113

Primary Children's Hospital, Salt Lake City

576104

Kasturba Medical College and Hospital, Manipal

02111

Tufts Children's Hospital at Tufts Medical Center, Boston

11 527

"Athens General Children's Hospital Panagioti and Aglaias Kyriakou", Athens

124 62

"ATTIKON University General Hospital", Chaïdári

546 42

"Hippokration General Hospital of Thessaloniki", Thessaloniki

00165

Ospedale Pediatrico Bambino Gesu, Rome

036 59

Univerzitna nemocnica Martin, Martin

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Allergan

INDUSTRY

lead

Pfizer

INDUSTRY

NCT04126031 - Evaluation of Pharmacokinetics, Safety, and Tolerability of Ceftazidime-avibactam in Neonates and Infants. | Biotech Hunter | Biotech Hunter