Evaluation of Safety, Pharmacokinetics and Efficacy of Ceftazidime and Avibactam (CAZ-AVI ) Compared With Cefepime in Children From 3 Months to Less Than 18 Years of Age With Complicated Urinary Tract Infections (cUTIs)

PHASE2CompletedINTERVENTIONAL
Enrollment

97

Participants

Timeline

Start Date

September 24, 2015

Primary Completion Date

September 15, 2017

Study Completion Date

September 15, 2017

Conditions
Complicated Urinary Tract Infections
Interventions
DRUG

Ceftazidime -avibactam

Patients randomised (3:1) to the CAZ-AVI or cefepime treatment

DRUG

Cefepime

Patients randomised (3:1) to the CAZ-AVI or cefepime treatment

Trial Locations (28)

100

National Taiwan University Hospital, Taipei

1097

Egyesitett Szent Istvan es Szent Laszlo Korhaz - Rendelointezet, Gyermekinfektologiai Osztaly, Budapest

2700

Toldy Ferenc Korhaz es Rendelointezet, Csecsemo- es Gyermekgyogyaszati Osztaly, Cegléd

7100

Tolna Megyei Balassa Janos Korhaz, Gyermekosztaly, Szekszárd

8800

Kanizsai Dorottya Korhaz, Csecsemo es Gyermekgyogyaszati Osztaly, Nagykanizsa

10449

Mackay Memorial Hospital, Taipei

11527

"General Children's Hospital Agia Sofia", Goudi

"General Children's Hospital of Athens P. & A. Kyriakou", Goudi

27157

Wake Forest University Health Sciences, Winston-Salem

35100

Ege Universitesi Tip Fakultesi, Izmir

40705

Taichung Veterans General Hospital, Taichung

41110

University General Hospital of Larissa, Larissa

43606

ProMedica Toledo Children's Hospital, Toledo

45030

Celal Bayar Universitesi Hafsa Sultan Hastanesi, Manisa

54642

"Hippokratio General Hospital of Thessaloniki", Thessaloniki

92123

Rady Children's Hospital San Diego, San Diego

97002

Hualien Tzu Chi Hospital Buddhist Tzu Chi Medical Foundation, Hualien City

119991

Federal State Budgetary Institution, Moscow

650066

"State Autonomous Healthcare Institution of Kemerovo Region Kemerovo Regional Clinical Hospital", Kemerovo

280 02

Lekarna Oblastni nemocnice Kolin, a.s., Kolin III

Oblastni nemocnice Kolin, a.s., nemocnice Stredoceskeho kraje - Detske oddeleni, Kolin III

434 64

Krajska Zdravotni, A.S. - Nemocnice Most, O.Z., Detske A Dorostove Oddeleni, Most

Lekarna Nemocnice Most., O.Z., Most

708 52

Fakultni Nemocnice Ostrava - Klinika Detskeho Lekarstvi, Ostrava - Poruba

Lekarna Fakultni Nemocnice Ostrava, Ostrava - Poruba

15-274

Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa w Bialymstoku, Bialystok

91-347

Wojewodzki Specjalistyczny Szpital im. dr W1. Bieganskiego, Lodz

030303

"Spitalul Clinic de Boli Infectioase si Tropicale Dr. Victor Babes, Sectia B2 Boli Infectioase", Bucharest

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

PRA Health Sciences

INDUSTRY

lead

Pfizer

INDUSTRY