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

NCT00303589 | Completed Phase 2

• 1 other identifier: WI18274
• Study Type: interventional
• Target: 313
• Locations: 11 countries
• Sites: 62

Brief Summary

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.

Conditions

Soft Tissue Infections

Outcome Measures

Primary Outcomes (1)

• Clinical cure rate.

  Event driven

Secondary Outcomes (4)

• Time to clinical cure

  Event driven

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

  Event driven

• Bacteriological outcome

  Event driven

• Adverse events; laboratory abnormalities

  Throughout study

Study Arms (3)

1

EXPERIMENTAL

Drug: beta-lactam

2

EXPERIMENTAL

Drug: beta-lactam

3

ACTIVE COMPARATOR

Drug: Standard care

Interventions

Standard care DRUG

As prescribed

3

beta-lactam DRUG

750mg iv q8h

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (62)

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Birmingham, Alabama, 35209, United States

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Mobile, Alabama, 36608, United States

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Melbourne, Florida, 32901, United States

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Miami Beach, Florida, 33139, United States

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Detroit, Michigan, 48201, United States

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Detroit, Michigan, 48202-2689, United States

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Minneapolis, Minnesota, 55422, United States

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Winston-Salem, North Carolina, 27103, United States

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Buenos Aires, 1282, Argentina

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Buenos Aires, 1430, Argentina

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Buenos Aires, 1657, Argentina

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Buenos Aires, 1888, Argentina

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Ciudadela, 1702, Argentina

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Córdoba, 5000, Argentina

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Córdoba, X5004CDT, Argentina

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El Palomar, 1684, Argentina

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Entre Ríos, 3100, Argentina

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Granadero Baigorria, 2152, Argentina

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Merlo, 1722, Argentina

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Neuquén, 8300, Argentina

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Rosario, 2000, Argentina

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Rosario, S2000DSV, Argentina

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Santa Fe, 3000, Argentina

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Pleven, 5800, Bulgaria

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Plovdiv, 4002, Bulgaria

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Sofia, 1606, Bulgaria

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Varna, 9000, Bulgaria

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Tallinn, 11312, Estonia

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Tallinn, 13419, Estonia

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Tartu, 51014, Estonia

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Lübeck, 23538, Germany

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Mainz, 55131, Germany

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München, 81377, Germany

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Münster, 48157, Germany

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Budapest, 1076, Hungary

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Budapest, H-1082, Hungary

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Győr, 9024, Hungary

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Liepāja, 3402, Latvia

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Riga, 1001, Latvia

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Riga, 1002, Latvia

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Riga, 1038, Latvia

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Kaunas, 50009, Lithuania

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Klaipėda, 92288, Lithuania

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Vilnius, 04130, Lithuania

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Vilnius, 08661, Lithuania

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Vilnius, 10207, Lithuania

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La Victoria, Lima, Lima 13, Peru

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Lima, 11, Peru

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Lima, 1, Peru

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Lima, Peru

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Bucharest, 014461, Romania

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Bucharest, 041914, Romania

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Cluj-Napoca, 400006, Romania

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Constanța, 900591, Romania

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Târgu Mureş, 540342, Romania

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Benoni, 1501, South Africa

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Cape Town, 7530, South Africa

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Middleburg, 1050, South Africa

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Port Elizabeth, 6020, South Africa

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Pretoria, 0082, South Africa

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Sommerset West, 7130, South Africa

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Themba, 0040, South Africa

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MeSH Terms

Conditions

Soft Tissue Infections

Interventions

Standard of Care; beta-Lactams

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2006
• First Posted: March 17, 2006
• Study Start: December 1, 2005
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

US (8); HU (3); ES (3); RO (5); ZA (7); AR (15); LA (4); LI (5); BU (4); DE (4); PE (4)