Ceftolozane/Tazobactam (MK-7625A) Plus Metronidazole Versus Meropenem for Participants With Complicated Intra-abdominal Infection (MK-7625A-015)

PHASE3CompletedINTERVENTIONAL
Enrollment

268

Participants

Timeline

Start Date

March 20, 2019

Primary Completion Date

October 14, 2020

Study Completion Date

October 14, 2020

Conditions
Complicated Intra-abdominal Infections
Interventions
DRUG

Ceftolozane/Tazobactam

Ceftolozane 1000 mg / tazobactam 500 mg by IV infusion every 8 hours for 4 to 14 days. Participants with CrCL of 30 to ≤ 50 mL/min will receive ceftolozane 500 mg / tazobactam 250 mg.

DRUG

Metronidazole

Metronidazole 500 mg by IV infusion every 8 hours for 4 to 14 days.

DRUG

Meropenem

Meropenem 1000 mg by IV infusion every 8 hours for 4 to 14 days. Participants with CrCL of 30 to ≤ 50 mL/min will receive IV infusion every 12 hours.

DRUG

Placebo

Saline by IV infusion every 8 hours for 4 to 14 days.

Trial Locations (25)

100048

Navy General Hospital ( Site 0009), Beijing

100191

Peking University Third Hospital ( Site 0002), Beijing

130022

The Second Hospital of Jilin University ( Site 0048), Changchun

200032

Zhongshan Hospital of Fudan University ( Site 0001), Shanghai

200080

Subei People's Hospital ( Site 0046), Yangzhou

Shanghai General Hospital ( Site 0016), Shanghai

201100

Central Hospital of Minhang District ( Site 0052), Shanghai

212000

Affiliated Hospital of Jiangsu University ( Site 0049), Zhenjiang

213000

The First People's Hospital of Changzhou ( Site 0054), Changzhou

214002

Wuxi No.2 People's Hospital ( Site 0050), Wuxi

214023

Wuxi People's Hospital ( Site 0020), Wuxi

230001

Anhui Provincial Hospital ( Site 0033), Hefei

252000

Liaocheng People s hospital ( Site 0014), Liaocheng

300121

Tianjin People's Hospital ( Site 0040), Tianjin

317000

Taizhou Hospital of Zhejiang Province ( Site 0035), Taizhou

325000

The 2nd Affiliated Hospital of Wenzhou Medical University ( Site 0051), Wenzhou

The First Affiliated Hospital of Wenzhou Medical University ( Site 0015), Wenzhou

330006

The First Affiliated Hospital of Nanchang University ( Site 0029), Nanchang

The Second Affiliated Hospital of Nanchang University ( Site 0053), Nanchang

510120

The First Affiliated Hospital of Guangzhou Medical University ( Site 0026), Guangzhou

510515

Southern Medical University Nanfang Hospital ( Site 0055), Guangzhou

570311

Hainan General Hospital ( Site 0042), Haikou

650200

The First Hospital of Kunming ( Site 0041), Kunming

830054

The First Affiliated Hospital of Xinjiang Medical University ( Site 0034), Ürümqi

014040

Baotou Central Hospital ( Site 0013), Baotou

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT03830333 - Ceftolozane/Tazobactam (MK-7625A) Plus Metronidazole Versus Meropenem for Participants With Complicated Intra-abdominal Infection (MK-7625A-015) | Biotech Hunter | Biotech Hunter