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NCT Number: NCT01371838

A Study to Evaluate the Efficacy and Safety of Intravenous Ceftaroline Versus Intravenous Ceftriaxone in the Treatment of Adult Hospitalised Patients With Community-Acquired Bacterial Pneumonia in Asia

This purpose of this study is to Evaluate the Efficacy and Safety of Intravenous Ceftaroline Versus Intravenous Ceftriaxone in the Treatment of Adult Hospitalised Patients With Community-Acquired Bacterial Pneumonia in Asia.

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Key information

Age range

18 year–150 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and females 18 or more years of age
  • Lung Infection of Individual not Recently Hospitalized meeting the following criteria: Radiographically-confirmed pneumonia (new or progressive infection site of the lungs) consistent with bacterial pneumonia), AND Acute illness (≤ 7 days duration) with at least three of the following clinical signs or symptoms consistent with lung infection: New or increased cough, Purulent sputum or change in sputum character, Auscultatory findings consistent with pneumonia, Difficulty in breathing, short breath, or decreased partial pressure of oxygen in blood, Fever greater than 38ºC oral or body temperature lower than that required for normal body function(< 35ºC), White blood cell count greater than or less than the normal, Greater than 15% immature neutrophils (bands) irrespective of white blood cell count, AND Moderate lung infection
  • The subject must require initial hospitalization, or treatment in an emergency room or urgent care setting, by the standard of care
  • The subject's infection would require initial treatment with intravenous antimicrobials
  • Female subjects of child-bearing potential, and those who are fewer than 2 years post-menopausal, must agree to, and comply with, using highly effective methods of birth control while participating in this study

Exclusion criteria

  • Lung Infection of Individual not Recently Hospitalized suitable for outpatient therapy with an oral antimicrobial agent
  • Confirmed or suspected respiratory tract infections attributable to sources other than bacteria from the individuals not recently hospitalized(e.g., ventilator-associated pneumonia, hospital-acquired pneumonia, visible/gross aspiration pneumonia, suspected viral, fungal, or mycobacterial infection of the lung)
  • Non-infectious causes of lung lesion (e.g., pulmonary embolism, chemical pneumonitis from aspiration, hypersensitivity pneumonia, congestive heart failure)
  • Accumulation of pus in the pleural cavity
  • Microbiologically-documented infection with a pathogen known to be resistant to ceftriaxone, or epidemiological or clinical context suggesting high likelihood of a ceftriaxone-resistant "typical" bacterial pathogen.

Treatment and study plan

ceftaroline

Drug

Two consecutive infusions q12h for 5 to 7 days

Ceftriaxone

Drug

One dose infusion followed by IV saline placebo infused q24h for 5 to 7 days plus two consecutive saline placebo infusion q24h.

Primary outcomes

  1. Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at Test of Cure (TOC) in CE Population

    Time frame: 7-20 days after last dose of study drug

    Cure:Total resolution of all signs and symptoms of pneumonia (ie,CABP), or improvement to such an extent that further antimicrobial therapy was not necessary Failure: Any of the following: •Persistence, incomplete clinical resolution, or worsening in signs and symptoms of CABP that required alternative antimicrobial therapy •Treatment-limiting AE leading to discontinuation of study drug therapy, when subject required alternative antimicrobial therapy to treat the pneumonia •Death wherein pneumonia (ie,CABP) was considered causative Indeterminate: Inability to determine an outcome

Secondary outcomes

  1. Clinical Response at End of Treatment (EOT) Visit in MITT Population

    Time frame: Last day of study drug administration

  2. Clinical Response at End of Treatment (EOT) Visit in CE Population

    Time frame: Last day of study drug administration

  3. Clinical Response at the Test of Cure (TOC) Visit in MITT Population

    Time frame: 7-20 days after last day of study drug administration

  4. Clinical Response at the Test of Cure (TOC) Visit in mMITT Population

    Time frame: 7-20 days after last day of study drug administration

  5. Clinical Response at the Test of Cure (TOC) Visit in ME Population

    Time frame: 7-20 days after last day of study drug administration

  6. Clinical Response at Test of Cure (TOC) Visit by Pathogen in ME Population

    Time frame: 7-20 days after last dose of study drug

  7. Per-Pathogen Microbiological Response at Test of Cure (TOC) Visit by Pathogen in ME Population

    Time frame: 7-20 days after last dose of study drug

  8. Per-Patient Microbiological Response at Test of Cure (TOC) Visit in mMITT Population

    Time frame: 7-20 days after last day of study drug administration

    An outcome is considered as favourable if the per-pathogen response for that subject is either Eradication (An adequate source specimen demonstrates absence of the original baseline pathogen) or presumed eradication (An adequate source specimen was not available to culture and the patient was assessed as a clinical cure). Here, an adequate source specimen is defined as any sample that may yield the growth of a CABP pathogen eg, blood, respiratory specimens, or pleural fluid.

  9. Per-Patient Microbiological Response at Test of Cure (TOC) Visit in ME Population

    Time frame: 7-20 days after last day of study drug administration

    An outcome is considered as favourable if the per-pathogen response for that subject is either Eradication (An adequate source specimen demonstrates absence of the original baseline pathogen) or presumed eradication (An adequate source specimen was not available to culture and the patient was assessed as a clinical cure). Here, an adequate source specimen is defined as any sample that may yield the growth of a CABP pathogen eg, blood, respiratory specimens, or pleural fluid.

  10. Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC) Visit in MITT Population

    Time frame: 7-20 days after last day of study drug administration

  11. Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC) Visit in CE Population

    Time frame: 7-20 days after last dose of study drug

  12. Clinical Relapse at the LFU Visit for Clinical Cure Patients at Test of Cure (TOC) Visit in MITT Population

    Time frame: 21-42 days after last day of study drug administration

  13. Clinical Relapse at the LFU Visit for Clinical Cure Patients at Test of Cure (TOC) Visit in CE Population

    Time frame: 21-42 days after last day of study drug administration

  14. Microbiological Re-infection/Recurrence at LFU Visit in mMITT Population

    Time frame: 21-42 days after last dose of study drug

  15. Microbiological Re-infection/Recurrence at LFU Visit in ME Population

    Time frame: 21-42 days after last dose of study drug

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • Forest Laboratories

Registry information

Official study title

A Phase III, Multicentre, Randomised, Double-Blind, Comparative Study to Evaluate the Efficacy and Safety of Intravenous Ceftaroline Versus Intravenous Ceftriaxone in the Treatment of Adult Hospitalised Patients With Community-Acquired Bacterial Pneumonia in Asia

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jun 13, 2011
Registry last updated
Sep 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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