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NCT01645735 · ClinicalTrials.gov registry record · Phase 4
Evaluation of Ceftaroline Fosamil Versus a Comparator in Adult Subjects With Community-acquired Bacterial Pneumonia (CABP) With Risk for Methicillin-resistant Staphylococcus Aureus
A Phase 4 study, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 4
- Development phase
- 49
- Enrollment target
NCT01645735: Completed Phase 4 study, sponsored by Forest Laboratories.
NCT01645735 is a Phase 4 study that has completed, run by Forest Laboratories. The registered enrollment target is 49 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01645735, a Phase 4 study, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 49 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether ceftaroline is effective and safe for the treatment of patients with Community-acquired Bacterial Pneumonia (CABP) at risk for infection due to Methicillin-resistant Staphylococcus aureus (MRSA).
Primary Outcome
Clinical response was defined as meeting all of the following criteria: * Symptom Improvement - Improvement in at least 2 and no worsening of any of the following symptoms compared to baseline: * Cough * Dyspnea * Sputum production * Chest pain * Clinical Stability (per Infectious Diseases Society of America/American Thoracic Society (IDSA/ATS) guidelines; Mandell et al, 2007): * Temperature ≤ 37.8°C * Heart rate ≤ 100 beats/min * Respiratory rate ≤ 24 breaths/min * Systolic b
Interventions
- DRUG Ceftaroline fosamil
- DRUG Ceftriaxone plus vancomycin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2012-10 |
| Est. Completion | 2013-12 |
| Phase | Phase 4 |
What the finished NCT01645735 record still lists
NCT01645735 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Ceftaroline fosamil is the first listed.
NCT01645735 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01645735 about?
NCT01645735 is a clinical study titled "Evaluation of Ceftaroline Fosamil Versus a Comparator in Adult Subjects With Community-acquired Bacterial Pneumonia (CABP) With Risk for Methicillin-resistant Staphylococcus Aureus". The purpose of this study is to determine whether ceftaroline is effective and safe for the treatment of patients with Community-acquired Bacterial Pneumonia (CABP) at risk for infection due to Methicillin-resistant Staphylococcus aureus (MRSA).
What is the current status of trial NCT01645735?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 49 participants. The study started on 2012-10. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01645735?
The interventions under investigation include: Ceftaroline fosamil (DRUG), Ceftriaxone plus vancomycin (DRUG).
Who is sponsoring clinical trial NCT01645735?
This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01645735's enrollment target sits among peer trials
49 1323rd of 2000 higher than 670 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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