A Phase II Study of Faropenem in the Treatment of Adult Community-acquired Bacterial Pneumonia

C

CTTQ

Status and phase

Completed
Phase 2

Conditions

Community Acquired Pneumonia

Treatments

Drug: Faropenem(low-dose group)
Drug: Faropenem(high dose group)
Drug: Ertapenem

Study type

Interventional

Funder types

Industry

Identifiers

NCT01886053
ZTDQ04104-CTF

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and Efficacy of Faropenem in community-acquired pneumonia (CAP) subjects,and explore its therapeutic dose.

Enrollment

189 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients aged between 18~70 years, either male or female
  • Patients requiring hospitalization or emergency room observation, and the need to receive intravenous antibiotic treatment
  • Women of childbearing age having negative pregnancy test at the time of enrollment and agreeing to take effective contraceptive measures from the delivery to 7 ~14 days after stopping .(for example: oral contraception, injectable contraception, or implant contraception , spermicides and condoms, or intrauterine device).

Comply with clinical, radiological and microbiological criteria of Community-Acquired Pneumonia(CAP):

  • Patients had used ineffective systemic antimicrobial drugs before enrollment or had effective antimicrobial drugs within 72 h before enrollment, used <24 h
  • Informed consent granted

Exclusion criteria

  • Patients with atypical pneumonia infected by the Mycoplasma pneumoniae, Chlamydia pneumoniae, Legionella pneumophila bacteria;
  • Patients infected by pathogens methicillin-resistant Staphylococcus aureus, Pseudomonas aeruginosa or Acinetobacter baumanns ;
  • Viral pneumonia;
  • Aspiration pneumonia;
  • Hospital-acquired pneumonia, including ventilator-associated pneumonia;
  • Patients with Severe pneumonia who meet one primary criterion or three secondary criteria (See Appendix);
  • Patients with a rapid progressive or end-stage disease, and can not survive until the end of the study period by antibiotic treatment;
  • Patients with bronchial obstruction or a history of obstructive pneumonia (not including chronic obstructive pulmonary disease);
  • Suffering from any of the following diseases: active tuberculosis, bronchiectasis, lung abscess, lung cancer, non-infectious interstitial lung disease, pulmonary edema, atelectasis, pulmonary embolism, pulmonary eosinophil infiltration disease and pulmonary vasculitis;
  • Infections acquired from hospitals, nursing homes or other long-term care facilities, or patients hospitalized within 14 days prior to enrollment ;
  • Allergic to penem and carbapenem antibiotic;
  • Pregnancy or lactation in women;
  • Patients with uncontrolled psychiatric history or those at risk of suicide two years prior to enrollment;
  • A history of epilepsy or other central nervous system disorders in patients;
  • Patients with Renal dysfunction, screening serum creatinine values above the upper limit of normal 10%;
  • The Screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is 3 times the upper limit of the reference value, or total bilirubin beyond the upper limit of the normal range by 10% ;
  • Serious diseases that affecting the immune system, such as: a human immunodeficiency virus (HIV) infection history, or cluster of differentiation 4 + T-lymphocyte count <200/200/mm3, or Neutrophilic granulocytopenia (neutrophil count <1500/mm3), or hematologic malignancies or solid organ or splenectomy, etc;
  • Patients who are taking steroid medications, at least 20 mg daily dose of prednisone(or equivalent doses of other glucocorticoids);
  • Patients who are accepting chemotherapy drug therapy or anti-cancer therapy, or plan to accept such treatment during the trial six months prior to enrollment;
  • Alcohol or illicit drug abuse history;
  • Patients who have accepted any other experimental drugs within 3 months prior to enrollment;
  • more than 500 ml blood donation within 3 months prior to enrollment;
  • Patients who have participated in this clinical trial ever before;
  • Combined use of other antibacterial drugs in patients;
  • Patients are diagnosed to have potential increased risks, or there may be interference with clinical trials;

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

189 participants in 3 patient groups

Ertapenem
Active Comparator group
Treatment:
Drug: Ertapenem
Faropenem(low-dose group)
Experimental group
Treatment:
Drug: Faropenem(low-dose group)
Faropenem(high dose group)
Experimental group
Treatment:
Drug: Faropenem(high dose group)

Trial contacts and locations

9

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Data sourced from clinicaltrials.gov

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