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

This study has been completed.
Sponsor:
Information provided by:
Cubist Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00538694
First received: October 1, 2007
Last updated: October 2, 2007
Last verified: October 2007
  Purpose

To evaluate the safety and efficacy of daptomycin in adults who have pneumonia due to Streptococcus pneumoniae.


Condition Intervention Phase
Pneumonia, Bacterial
Drug: daptomycin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Official Title: A Randomized, Double-Blind, Phase III, Comparative Study of Cidecin™ (Daptomycin) to Rocephin® (Ceftriaxone) in the Treatment of Moderate to Severe Community-Acquired Acute Bacterial Pneumonia Due to S. Pneumoniae

Resource links provided by NLM:


Further study details as provided by Cubist Pharmaceuticals:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  1. Provide signed and dated informed consent.
  2. Adults, 18 years of age or older of either gender and of any race. 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 28 days after treatment with study drug(s).
  3. Must exhibit clinical signs/symptoms and radiographic appearance of pneumonia: presence of new pulmonary infiltrate on chest radiograph; fever (oral >38.0C/100.4F); and at least one of the following signs and symptoms consistent with the diagnosis of acute bacterial pneumonia: acute onset, chills, chest pain/dyspnea, cough, or sputum production.
  4. Pneumonia which: requires hospitalization; requires IV antibiotic therapy; anticipated 5 days IV therapy; and (for Grade II) O2 saturation <90% and PaO2 <60 mmHg on room air.
  5. Provide a suitable sputum specimen for Gram's-stain and culture. If expectorated sputum or transtracheal aspirate: >10 lancet-shaped Gram-positive diplococci/oil-immersion field (1000); <10 squamous epithelial cells/low-power field (100); >25 leukocytes/low-power field (100).
  6. 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.
  7. Willingness to participate in this study and to complete all follow-up assessments.

Exclusion Criteria:

  1. Grade I pneumonia risk classification, or Grade II with O2 saturation >90% on room air and/or PaO2 >60 mmHg on room air (based on Fine Score; Attachment 8).
  2. Patients with Grade V pneumonia (based on Fine Score; Attachment 8).
  3. Respiratory failure without mechanical ventilatory support (i.e., PaO2 / FiO2 <200), or underlying lung disease precluding interpretation of study results (e.g., cystic fibrosis, lung cancer).
  4. Loculated empyema.
  5. Severe shock (systolic blood pressure <90 mm Hg for >30 minutes not corrected by fluid bolus).
  6. Clinical evidence of bacterial meningitis (based on lumbar puncture results).
  7. Renal impairment (calculated creatinine clearance <30 mL/min); hepatic dysfunction (ALT/AST more than 3 times the upper limit of normal or bilirubin 2.0 mg/dL); or clinical or histologic diagnosis of cirrhosis or another form of chronic liver disease, such as chronic active hepatitis.
  8. Moribund clinical condition: high likelihood of death during the first 48 hours.
  9. Patients who are severely immunocompromised due to underlying disease or exogenous therapies, CD4 counts <100/mm3.
  10. Inability to tolerate ceftriaxone or history of allergy to  lactam antibiotics (history of rash alone will not exclude a patient).
  11. Any individual previously treated with a potentially effective anti-infective agent for 24 hours immediately prior to enrollment, or prior treatment with any investigational drug (including experimental biologic agents) in previous 30 days or prior therapy with daptomycin.
  12. Patients who must continue HMG-CoA reductase inhibitor therapy (e.g., simvastatin, lovastatin, etc) during the study treatment period.
  13. Use of >0.5 mg/kg/day prednisone or equivalent for >1 week preceding enrollment.
  14. Anticipation that a second systemic antibiotic will be required.
  15. Induction chemotherapy within 2 weeks prior to enrollment (or exogenous therapies which are anticipated to result in PMN counts of <200 mm3 during Treatment Phase), or patients with severe neutropenia (<200 PMN cells/mm3).
  16. Patients considered unreliable to return for visits or to comply with study procedures.
  17. Functionally or surgically asplenic (e.g., sickle cell disease, multiple myeloma).
  18. Neoplastic disease, except basal cell or squamous cell cancer of the skin that was active at the time of enrollment or within 1 year prior to enrollment.
  19. Women who are pregnant or nursing/lactating.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00538694     History of Changes
Other Study ID Numbers: DAP-00-05
Study First Received: October 1, 2007
Last Updated: October 2, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Cubist Pharmaceuticals:
Moderate to severe community-acquired acute bacterial pneumonia due to S. Pneumoniae

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Bacterial
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Bacterial Infections
Daptomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014