Skip to content

Ertapenem versus Ceftriaxone and Metronidazole As Treatment For Complicated Intra-abdominal Infections

A Prospective, Multicenter, Open-Label, Randomized, Comparative Study to Evaluate the Efficacy, Safety, and Tolerability of Ertapenem Versus Ceftriaxone/Metronidazole in the Treatment of Intra-Abdominal Infections in Adults

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN59616541
Enrollment
500
Registered
2005-01-19
Start date
2002-06-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Complicated intra-abdominal infections Infections and Infestations Other and unspecified infectious diseases

Interventions

Current information as of 13/08/09: Adult patients with intra-abdominal infections requiring surgery were eligible for this open-label randomized trial comparing ertapenem 1 g daily with ceftriaxone 2

Sponsors

Merck and Co., Inc. (USA)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Current information as of 13/08/09: 1. Male or female patients aged 18 or over 2. Patient has a diagnosis of intra-abdominal infection requiring surgery as evidenced by fever, elevated while blood cell count and abdominal pain Initial information at time of registration: Adult patients with intra-abdominal infections requiring surgery

Exclusion criteria

Exclusion criteria: Added 13/08/09: 1. Patient has another infection, other than abdominal 2. Female patient is pregnant or planning to become pregnant

Design outcomes

Primary

MeasureTime frame
Added 13/08/09: Efficacy as measured by clinical response rate in clinically and microbiologically evaluable participants at the test-of-cure (TOC) visit 2 weeks after discontinuation of therapy

Secondary

MeasureTime frame
Added 13/08/09: Efficacy measured at TOC visit 4 weeks after discontinuation of therapy

Countries

Philippines

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026