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OpenTrials
Completed

NCT Number: NCT00303589

A Study of Beta-Lactam in Hospitalized Patients With Skin and Skin Structure Infections

This 3 arm study will compare the efficacy and safety of beta-lactam with that of 'standard care' in patients with complicated skin and skin structure infections requiring hospitalization. Patients will be randomized to receive 1)beta-lactam 750mg iv q8h 2)beta-lactam 1500mg iv q8h or 3)'standard care' [PRP (nafcillin or flucloxacillin) or vancomycin, plus aztreonam or ciprofloxacin]. The anticipated time on study treatment is <3 months and the target sample size is 100-500 individuals.

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Key information

Conditions

Soft Tissue Infections Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult patients, >=18 years of age;
  • skin or skin structure infection requiring hospitalization;
  • clinical diagnosis of a skin or skin structure infection caused by bacteria known or suspected to be susceptible to the randomized study treatment;
  • material from site of infection is clinically purulent or seropurulent.

Exclusion criteria

  • presenting with sustained shock (SBP<90mm Hg for > 2 hours, despite adequate fluid resuscitation);
  • known or suspected concomitant bacterial infection requiring antibiotic treatment;
  • skin infection or chronic non-healing ulcer of > 2 weeks duration;
  • patients in whom surgery is the primary treatment.

Treatment and study plan

Standard care

Drug

As prescribed

beta-lactam

Drug

750mg iv q8h

Primary outcomes

  1. Clinical cure rate.

    Time frame: Event driven

Secondary outcomes

  1. Time to clinical cure

    Time frame: Event driven

  2. Time to resolution of signs and symptoms of skin or soft tissue infection

    Time frame: Event driven

  3. Bacteriological outcome

    Time frame: Event driven

  4. Adverse events; laboratory abnormalities

    Time frame: Throughout study

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Phase II Prospective, Open Label, Randomized, Active-controlled, Parallel Group, Multi-center 'Proof of Concept' Trial in Adult Patients With Complicated Skin or Skin Structure Infections Requiring Hospitalization.

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Mar 17, 2006
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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