NCT01937832

Brief Summary

The purpose of this study is to evaluate the safety and Efficacy of Faropenem in community-acquired pneumonia (CAP) subjects

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
540

participants targeted

Target at P75+ for phase_3

Geographic Reach
1 country

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 10, 2013

Completed
21 days until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Last Updated

September 10, 2013

Status Verified

September 1, 2013

Enrollment Period

2 years

First QC Date

September 4, 2013

Last Update Submit

September 4, 2013

Conditions

Community Acquired Pneumonia

Outcome Measures

Primary Outcomes (1)

  • Per subject clinical cure rate

    7-14 days

Study Arms (2)

Ertapenem

ACTIVE COMPARATOR
Drug: Ertapenem

Faropenem

EXPERIMENTAL
Drug: Faropenem

Interventions

FaropenemDRUG

dosage form: Injection dosage:1200 mg frequency: Three times a day

Faropenem
ErtapenemDRUG

dosage form: Injection dosage:1000 mg frequency: once a day

Ertapenem

Eligibility Criteria

Age18 Years - 73 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged between18\~73 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 IUDs).
  • Comply with the following 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 72h before enrollment, used \<24h
  • Informed consent granted

You may not qualify if:

  • Patients with atypical pneumonia infected by the Mycoplasma pneumoniae, Chlamydia pneumoniae, Legionella pneumophila bacteria;
  • Patients infected by pathogens MRSA, Pseudomonas aeruginosa or Acinetobacter baumannii;
  • 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%;
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Anhui Provincial Hospital

Hefei, Anhui, 230001, China

Location

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

Location

Taihe Hospital in Shiyan City

Shiyan, Hubei, 442000, China

Location

The Second Hospital of Jilin University

Changchun, Jilin, China

Location

Qingdao Municipal Hospital

Qingdao, Shandong, 266000, China

Location

Huashan Hospital ,Fudan University

Shanghai, 200040, China

Location

The Second Hospital of Tianjin Medical University

Tianjin, 300211, China

Location

MeSH Terms

Conditions

Community-Acquired Pneumonia

Interventions

fropenemErtapenem

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsPneumoniaRespiratory Tract InfectionsRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Carbapenemsbeta-LactamsLactamsAmidesOrganic ChemicalsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Central Study Contacts

Wu Ju Fang

CONTACT

13816357099Wujf53@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2013

First Posted

September 10, 2013

Study Start

October 1, 2013

Primary Completion

October 1, 2015

Last Updated

September 10, 2013

Record last verified: 2013-09

Locations

CN(7)