- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00538694
Comparative Study of Cidecin™ (Daptomycin) to Rocephin® (Ceftriaxone) in the Treatment of Moderate to Severe Community-Acquired Acute Bacterial Pneumonia
November 13, 2019 updated by: Cubist Pharmaceuticals LLC
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
To evaluate the safety and efficacy of daptomycin in adults who have pneumonia due to Streptococcus pneumoniae.
Study Overview
Study Type
Interventional
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Provide signed and dated informed consent.
- 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).
- Must exhibit clinical signs/symptoms and radiographic appearance of pneumonia: presence of new pulmonary infiltrate on chest radiograph; fever (oral >38.0 degree C/100.4 degree 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.
- 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.
- 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 (1000x); <10 squamous epithelial cells/low-power field (100x); >25 leukocytes/low-power field (100x).
- 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.
- Willingness to participate in this study and to complete all follow-up assessments.
Exclusion Criteria:
- 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).
- Patients with Grade V pneumonia (based on Fine Score; Attachment 8).
- 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).
- Loculated empyema.
- 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).
- 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.
- Moribund clinical condition: high likelihood of death during the first 48 hours.
- Patients who are severely immunocompromised due to underlying disease or exogenous therapies, CD4 counts <100/mm3.
- 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 immediately prior to 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.
- Use of >0.5 mg/kg/day prednisone or equivalent for >1 week preceding enrollment.
- Anticipation that a second systemic antibiotic will be required.
- 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).
- Patients considered unreliable to return for visits or to comply with study procedures.
- Functionally or surgically asplenic (e.g., sickle cell disease, multiple myeloma).
- 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.
- Women who are pregnant or nursing/lactating.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 31, 2000
Primary Completion (Actual)
September 30, 2001
Study Completion (Actual)
September 30, 2001
Study Registration Dates
First Submitted
October 1, 2007
First Submitted That Met QC Criteria
October 2, 2007
First Posted (Estimate)
October 3, 2007
Study Record Updates
Last Update Posted (Actual)
November 14, 2019
Last Update Submitted That Met QC Criteria
November 13, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DAP-00-05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pneumonia, Bacterial
-
Omnix Medical LtdNot yet recruitingVentilator-associated Bacterial Pneumonia | Hospital-acquired Bacterial Pneumonia
-
Evopoint Biosciences Inc.RecruitingHospital Acquired Bacterial Pneumonia or Ventilator-Associated Bacterial PneumoniaUnited States, Spain, France, Israel
-
Merck Sharp & Dohme LLCCompletedHospital-Acquired Bacterial Pneumonia | Ventilator-Associated Bacterial PneumoniaMexico, Brazil, China, France, Philippines, Romania, Russian Federation, Ukraine
-
Massachusetts General HospitalUnited States Agency for International Development (USAID)UnknownInfections - Bacterial | Pneumonia - BacterialPakistan
-
Melinta Therapeutics, Inc.WithdrawnHospital-Acquired Bacterial Pneumonia | Ventilator-Associated Bacterial Pneumonia | Hospital-Acquired Pneumonia | Ventilator-Associated Pneumonia
-
Ayşe AKBIYIKCompletedVentilator-associated Bacterial Pneumonia
-
Melinta Therapeutics, Inc.CompletedCommunity Acquired Bacterial PneumoniaUnited States, Argentina, Bulgaria, Colombia, Dominican Republic, Georgia, Germany, Hungary, Latvia, Peru, Poland, Romania, Russian Federation, Serbia, Slovenia, South Africa, Spain, Ukraine
-
Melinta Therapeutics, Inc.CompletedCommunity-acquired Bacterial PneumoniaSpain, United States, Hungary, Canada, Estonia, Russian Federation, Argentina, Bulgaria, Czech Republic, Dominican Republic, Ecuador, Germany, Latvia, Poland, Puerto Rico, Romania, South Africa
-
Melinta Therapeutics, Inc.CompletedCommunity-acquired Bacterial PneumoniaSpain, United States, Philippines, Taiwan, Canada, Germany, Poland, Russian Federation, Argentina, Bulgaria, South Africa, Slovenia, Serbia, Colombia, Hungary, Netherlands, Slovakia, Ukraine, Peru, Latvia, Guatemala, Romania, Chile, G... and more
-
Zai Lab (Hong Kong), Ltd.RecruitingCommunity-acquired Bacterial PneumoniaChina
Clinical Trials on daptomycin
-
Cubist Pharmaceuticals LLCTerminatedWound Infections
-
Cubist Pharmaceuticals LLCCompletedGram Positive Infection | Concurrent Antibiotic TreatmentUnited States
-
Cubist Pharmaceuticals LLCCompletedBacteremia | Bacterial Endocarditis
-
University Hospital, CaenCompletedPeritoneal InfectionFrance
-
Merck Sharp & Dohme LLCCompleted
-
Cubist Pharmaceuticals LLCTerminatedGram-Positive Bacterial Infections
-
University of Maryland, BaltimoreCubist Pharmaceuticals LLCCompletedFasciitis, Necrotizing | Fournier's Gangrene | Severe Necrotizing Skin and Soft Tissue InfectionsUnited States
-
Cubist Pharmaceuticals LLCCompletedGram-positive Bacterial InfectionsUnited States
-
Cubist Pharmaceuticals LLCCompleted
-
Cubist Pharmaceuticals LLCTerminatedInfective EndocarditisUnited States