A Study to Assess Beta-Lactam in the Treatment of Hospitalized Patients With Bacterial Pneumonia

NCT00111644 | Completed Phase 2

• 1 other identifier: WI18273
• Study Type: interventional
• Target: 302
• Locations: 11 countries
• Sites: 49

Brief Summary

This study will assess the efficacy and safety of intravenous beta-lactam, in comparison with ceftriaxone, in hospitalized patients with community-acquired pneumonia not caused by Legionella. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.

Conditions

Pneumonia, Bacterial

Outcome Measures

Primary Outcomes (1)

• Clinical cure rate\n\n

  End of study visit (7-10 days after end of treatment)

Secondary Outcomes (1)

• Adverse events, vital signs, laboratory parameters\n

  Throughout study

Study Arms (3)

1

EXPERIMENTAL

Drug: beta-lactam

2

EXPERIMENTAL

Drug: beta-lactam

3

ACTIVE COMPARATOR

Drug: Ceftriaxone

Interventions

Ceftriaxone DRUG

1000mg iv daily

3

beta-lactam DRUG

750mg iv q 23h for 3-14 days

1

Eligibility Criteria

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

You may qualify if:

• male or female patients at least 18 years of age;
• hospitalization with community-acquired pneumonia or development of pneumonia within 48 hours of being hospitalized for another reason;
• fever;
• new or increased productive cough;
• chest pain, shortness of breath, or rapid breathing.

You may not qualify if:

• requiring intubation or ventilation;
• nursing home or extended care within 60 days before study;
• concomitant bacterial infection requiring antibiotics;
• long-term immunosuppressive therapy.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (49)

Unknown Facility

New Orleans, Louisiana, 70112, United States

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Shreveport, Louisiana, 71105, United States

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Detroit, Michigan, 48201, United States

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Butte, Montana, 59701, United States

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Holmdel, New Jersey, 07733, United States

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Winston-Salem, North Carolina, 27103, United States

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Buenos Aires, 1180, Argentina

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Buenos Aires, 1282, Argentina

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Buenos Aires, 1427, Argentina

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Buenos Aires, 1602, Argentina

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Buenos Aires, 1657, Argentina

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Buenos Aires, 1888, Argentina

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Buenos Aires, BUE1430, 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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Granadero Baigorria, 2152, Argentina

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Paraná, 3100, Argentina

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Rosario, S2000DSV, Argentina

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Rousse, 7002, Bulgaria

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Sofia, 1233, Bulgaria

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Sofia, 1431, Bulgaria

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Sofia, 1606, Bulgaria

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Santiago, Chile

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Valdivia, Chile

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Zagreb, 10000, Croatia

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Budapest, 1529, Hungary

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Nyíregyháza, 4400, Hungary

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Törökbálint, 2045, Hungary

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Zalaegerszeg, 8900, Hungary

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Daugavpils, 5417, Latvia

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Riga, 1038, Latvia

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Riga, LV-1002, Latvia

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Kaunas, 3000, Lithuania

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Klaipėda, 92231, Lithuania

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Vilnius, 08661, Lithuania

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Lima, 11, Peru

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Lima, 1, Peru

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Lima, 31, Peru

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Bucharest, 030303, Romania

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Bucharest, 21105, Romania

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Bucharest, 21659, Romania

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Bucharest, Romania

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Constanța, 8700, Romania

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Craiova, 200515, Romania

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Banská Bystrica, 975 17, Slovakia

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Nitra, 949 88, Slovakia

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Nitra, 950 01, Slovakia

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Unknown Facility

Poprad, 058 87, Slovakia

Location

MeSH Terms

Conditions

Pneumonia, Bacterial

Interventions

Ceftriaxone; beta-Lactams

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cefotaxime; Cephacetrile; Cephalosporins; Lactams; Amides; Organic Chemicals; Thiazines; 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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2005
• First Posted: May 25, 2005
• Study Start: March 1, 2005
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2007
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

LA (3); BU (4); HU (4); US (6); LI (3); PE (3); SL (4); CR (1); AR (13); CL (2); RO (6)