Study of Cidecin™ (Daptomycin) to Rocephin® (Ceftriaxone) in the Treatment of Moderate to Severe Community-Acquired Acute Bacterial Pneumonia Due to S. Pneumoniae

NCT00540072 | Completed Phase 3

• 1 other identifier: DAP-CAP-00-08
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

A COMPARASON OF CIDECIN™ (DAPTOMYCIN) TO ROCEPHIN® (CEFTRIAXONE) IN THE TREATMENT OF MODERATE TO SEVERE COMMUNITY-ACQUIRED ACUTE BACTERIAL PNEUMONIA DUE TO S. PNEUMONIAE

Conditions

Pneumonia, Bacterial

Keywords

Moderate to Severe Community-Acquired Acute Bacterial Pneumonia Due to S. Pneumoniae

Interventions

daptomycin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide signed and dated informed consent.
• Adults, 18 years of age or older of either gender and of any race weighing up to 150 kg. Female patients of childbearing potential MUST be nonpregnant (confirmed by negative serum pregnancy test), nonlactating, and must be willing to practice reliable birth control measures during and for at least 30 days after treatment with study drug(s).
• Have a new pulmonary infiltrate on chest radiograph.
• Exhibit at least two of the following clinical symptoms of pneumonia on history or physical:
• Cough
• Production of purulent sputum or change in character of sputum
• Auscultatory findings on pulmonary examination of rales and/or evidence of pulmonary consolidation (dullness to percussion, bronchial breath sounds, or egophony)
• Dyspnea or tachypnea
• Documented fever, defined as body temperature \>38.0 ºC (100.4 ºF) taken orally; \>38.5 ºC (101.2 ºF) tympanically; or \>39.0 ºC (102.2 ºF) rectally or hypothermia, defined as core body temperature of \<35.0 ºC (95.0 ºF)
• An elevated total peripheral white blood cell count (WBC \>10,000/mm3); or \>15% immature neutrophils (bands), regardless of total peripheral white count; or leukopenia with total WBC \<4500/mm3.
• Hypoxemia with a PO2 \< 60 mmHg (on room air) or O2 saturation \<90% on room air
• Pneumonia which requires hospitalization and intravenous therapy for at least 5 days.
• Willingness to participate in this study and to complete all follow-up assessments.

You may not qualify if:

• Patients with Grade V pneumonia (based on Fine Score; Attachment 8).
• Patients in respiratory failure or incipient respiratory failure if the patient is not a candidate for mechanical ventilation (for any reason).
• Any of the following pulmonary conditions that may preclude interpretation of study results:
• Cystic fibrosis
• Primary lung cancer or another malignancy metastatic to the lungs
• Known bronchial obstruction or a history of post-obstructive pneumonia
• Known or suspected active tuberculosis.
• Severe shock (systolic blood pressure \<90 mm Hg for \>30 minutes not corrected by fluid bolus).
• Clinical evidence of bacterial meningitis (based on lumbar puncture results).
• Severe renal impairment (calculated creatinine clearance \<30 mL/min).
• Moribund clinical condition: high likelihood of death during the first 48 hours.
• If HIV positive, known CD4 counts \<200/mm3 or evidence of Pneumocystis carinii pneumonia.
• Inability to tolerate ceftriaxone or history of allergy to beta-lactam antibiotics (history of rash alone will not exclude a patient).
• Any individual previously treated with a potentially effective anti-infective agent for \> 24 hours (or one dosing day) within 72 hours of enrollment, or prior treatment with any investigational drug (including experimental biologic agents) in previous 30 days or prior therapy with daptomycin.
• Patients who must continue HMG-CoA reductase inhibitor therapy (e.g., simvastatin, lovastatin, etc.) during the study treatment period.

Sponsors & Collaborators

• Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA): lead

Related Publications (1)

• Pertel PE, Bernardo P, Fogarty C, Matthews P, Northland R, Benvenuto M, Thorne GM, Luperchio SA, Arbeit RD, Alder J. Effects of prior effective therapy on the efficacy of daptomycin and ceftriaxone for the treatment of community-acquired pneumonia. Clin Infect Dis. 2008 Apr 15;46(8):1142-51. doi: 10.1086/533441.

  PMID: 18444848 RESULT

MeSH Terms

Conditions

Pneumonia, Bacterial

Interventions

Daptomycin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2007
• First Posted: October 5, 2007
• Study Start: July 30, 2001
• Primary Completion: February 27, 2002
• Study Completion: February 27, 2002
• Last Updated: November 14, 2019

Record last verified: 2019-11