Evaluation of Safety,Pharmacokinetics and Efficacy of CAZ-AVI With Metronidazole in Children Aged 3 Months to 18 Years Old With Complicated Intra-abdominal Infections (cIAIs).

PHASE2CompletedINTERVENTIONAL
Enrollment

83

Participants

Timeline

Start Date

August 1, 2015

Primary Completion Date

June 1, 2017

Study Completion Date

June 1, 2017

Conditions
Complicated Intra-abdominal Infections
Interventions
DRUG

Ceftazidime -avibactam

Randomisation (3:1) to ceftazidime -avibactam plus metronidazole or meropenem treatment

DRUG

Meropenem

Randomisation (3:1) to CAZ AVI plus metronidazole or meropenem treatment

DRUG

Metronidazole

Randomisation (3:1) to ceftazidime -avibactam plus metronidazole or meropenem treatment

Trial Locations (35)

1094

Semmelweis Egyetem, II. sz. Gyermekgyogyaszati Klinika, Budapest

6720

Szegedi Tudomanyegyetem, Szent-Gyorgyi Albert Klinikai Kozpont, Szeged

7100

Tolna Megyei Balassa Janos Korhaz, Gyermekgyogyaszati Osztaly, Szekszárd

7623

Pecsi Tudomanyegyetem, AOK, Klinikai Kozpont, Gyermekgyogyaszati Klinika, Pécs

8800

Kanizsai Dorottya Korhaz, Csecsemo es Gyermekgyogyaszati Osztaly, Nagykanizsa

10449

Department of Pediatrics, Mackay Memorial Hospital, Taipei

11527

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

26040

Eskisehir Osmangazi Universitesi Saglik Uygulama ve Arastirma Hastanesi, Eskişehir

28040

Hospital Clinico San Carlos, Madrid

Hospital Universitario Fundacion Jimenez Diaz, Madrid

40705

Taichung Veterans General Hospital, Taichung

43606

ProMedica Toledo Children's Hospital, Toledo

45030

Celal Bayar Universitesi Hafsa Sultan Hastanesi, Manisa

46026

Hospital Universitario y Politecnico la Fe, Valencia

54642

"General Hospital of Thessaloniki Hippokratio", Thessaloniki

74136

The Children's Hospital at Saint Francis, Tulsa

81362

Kaohsiung Veterans General Hospital, Kaohsiung City

92123

Rady Children's Hospital San Diego, San Diego

92868

CHOC Children's, Orange

214019

State Budgetary Educational Institution of Higher Professional Education, Smolensk

700309

"Spitalul Clinic de Urgenta pentru Copii Sf. Maria Iasi, Sectia Chirurgie Pediatrica II", Iași

280 00

Oblastni Nemocnice Kolin, a.s., Nemocnice Stredoceskeho Kraje, Detske oddeleni, Kolin III

280 02

Lekarna Oblastni Nemocnice Kolin, a.s., 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

140 59

Lekarna Thomayerovy Nemocnice, Praha 4 - Krc

Thomayerova Nemocnice, Klinika detske chirurgie a traumatologie 3.LF UK a TN, Praha 4 - Krc

386 29

Lekarna Nemocnice Strakonice, Strakonice

Nemocnice Strakonice, a.s. - Detske oddeleni, Strakonice

20-093

Uniwersytecki Szpital Dzieciecy w Lublinie, Lublin

08916

Hospital Universitario Germans Trias i Pujol, Badalona

08950

Hospital de Sant Joan de Deu, Esplugues de Llobregat

01330

Cukurova Universitesi Tip Fakultesi Balcali Hastanesi, Adana

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT02475733 - Evaluation of Safety,Pharmacokinetics and Efficacy of CAZ-AVI With Metronidazole in Children Aged 3 Months to 18 Years Old With Complicated Intra-abdominal Infections (cIAIs). | Biotech Hunter | Biotech Hunter