CClinicalTrials.gg
Sign In
CompletedNCT00619710Updated Sep 1, 2017

Complicated Skin and Skin Structure Infections

A Phase 3 interventional study of Meropenem and Imipenem-cilastatin in Skin Infection, Abscess and Cellulitis, sponsored by Pfizer. Completed. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2017-09-01.

Sponsored by Pfizer · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,000
Allocation
Randomized
Ages
13 Years and older
Sex
All
01

Study summary

The purpose of this study is to demonstrate the non-inferiority of meropenem (Merrem) and imipenem in hospitalised subjects with complicated skin and skin structure infections.

02

Conditions studied

  • Skin Infection
  • Abscess
  • Cellulitis

Keywords

  • skin infections
  • MERREM
  • PRIMAXIN IV
  • complex abscess
  • perirectal abscess
  • wound infections
  • infected ischemic/diabetic ulcers
  • cellulitis
  • Meropenem
  • Imipenem-cilastatin
03

In context

Infections

6,688 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 120 across 4,201 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Subjects are hospitalized males and females, aged 13 years or older, with clinical evidence of complicated skin and skin structure bacterial infection with material suitable for culture from 1 primary site of infections
  • Within 72 hours before enrollment or at the time of enrollment, all subjects must provide an appropriate specimen for culture and susceptibility testing
  • Subjects who have been given prior antibacterial therapy within 14 days of trial entry may be entered only if a culture is obtained showing persistence of a pathogen in blood or at the site of infection

Exclusion criteria

Exclusion Criteria:

  • Subjects with a known or suspected hypersensitivity to cephalosporins, penicillins, or carbapenems
  • Subjects with a history of seizure disorders or subjects currently receiving antiepileptic medication
  • Subjects with underlying infections or conditions which would interfere with evaluation of this study
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
1,000 participants (estimated)

Study arms

  • Experimental
    1

    Meropenem

    Drug: Meropenem

  • Active comparator
    2

    Imipenem-cilastatin

    Drug: Imipenem-cilastatin

Interventions

  • DrugMeropenem

    Intravenous

    Also known as: Merrem

  • DrugImipenem-cilastatin

    Intravenous

    Also known as: Primaxin

06

What researchers measure

Primary outcomes

  1. The primary measure is clinical response after all antibacterial treatment is stopped).

    Time frame: 7-28 days

Secondary outcomes

  1. clinical and microbiological response

    Time frame: Twice 3-28 days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00619710
Lead sponsor
Pfizer
First posted
Feb 21, 2008
Start date
Feb 2001
Primary completion
Dec 2003
Completion
Apr 2004
Last update
Sep 1, 2017
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Infections→

Other studies from this sponsor

Pfizer

Start the discussion