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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

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
REPEC
Registry ID
PER-063-01
Enrollment
23
Registered
2001-10-11
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

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

Conditions

None listed

Interventions

Group 1 Type of group
Comparator: ceftriaxone sodium / Duration of Treatment: 8 Weeks Group name:Group 3 Type of group
Comparator: metronidazole / Duration of Treatment: 8 Weeks

Sponsors

MERCK SHARP & DOHME PERU S.R.L.,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: -Male or female patients age 18 or older -Patient has a diagnosis of intra-abdominal infection requiring surgery as evidenced by fever, elevated while blood cell count and abdominal pain

Exclusion criteria

Exclusion criteria: - Patient has another infection, other than abdominal - Female patient is pregnant or planning to become pregnant

Design outcomes

Primary

MeasureTime frame
Outcome name:That ertapenem is as effective as ceftriaxone/metronidazole in the treatment of an abdominal infection Measure:Efficacy Timepoints:2 weeks after treatment—

Secondary

MeasureTime frame
Outcome name:That ertapenem is as effective as ceftriaxone/metronidazole in the treatment of an abdominal infection Measure:Efficacy Timepoints:4 weeks after treatment—

Contacts

Public ContactStela Lopez

MERCK SHARP & DOHME PERU S.R.L

stela_lopez@merck.com4115935

Outcome results

None listed

Source: REPEC (via WHO ICTRP)