NCT00336544|CompletedPhase 3Results

Study Comparing the Safety and Efficacy of Cethromycin to Clarithromycin for the Treatment of Community-Acquired Pneumonia

A Double-Blinded, Randomized, Parallel Group, Multi-Center, Multi-National Comparative Study of the Safety and Efficacy of Cethromycin 300 mg QD to Clarithromycin 250 mg BID for the Treatment of Community-Acquired Pneumonia in Adults

Advanced Life Sciences, Inc.ClinicalTrials.gov

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1 other identifier

CL06-001

Study Type

interventional

Target

522

Locations

1 country

Sites

Timeline

RegisteredJun 2006

StartedJun 2006

CompletionMay 2007

Brief Summary

The purpose of this study is to compare the efficacy and safety of cethromycin to clarithromycin for the treatment of mild to moderate community-acquired pneumonia (CAP).

Trial Health

On Track

Trial Health Score

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

Enrollment

522

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Jun 2006

Shorter than P25 for phase_3

Geographic Reach

1 country

13 active sites

Status

completed

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

11 months study duration

Study Start

First participant enrolled

June 1, 2006

Completed

8 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2006

Completed

4 days until next milestone

First Posted

Study publicly available on registry

June 13, 2006

Completed

11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed

2.8 years until next milestone

Results Posted

Study results publicly available

February 26, 2010

Completed

Last Updated

February 26, 2010

Status Verified

January 1, 2010

Enrollment Period

11 months

First QC Date

June 9, 2006

Results QC Date

September 3, 2009

Last Update Submit

January 29, 2010

Conditions

Pneumonia

Keywords

PneumoniaRespiratoryInfectionInfectiousAdvancedLifeSciencesLungPulmonaryCethromycinClarithromycinBiaxin

Outcome Measures

Primary Outcomes (2)

Clinical Cures in the Intent to Treat Population
Investigators evaluated subjects for a clinical response of cure, failure, or indeterminate. Cure: Improvement or return to preinfection state or lack of progression of all pulmonary infiltrates, and resolution of all signs/symptoms present at enrollment. Failure: Persistence or worsening of signs/symptoms, the need for additional antibiotic, new pulmonary infection, progression of the chest radiograph, or death due to pneumonia. Indeterminate: Evaluation was not possible (lost to follow up, adverse event, major protocol violation). Indeterminates default to failure for analysis.
Test of Cure Visit, defined as 14-22 days after the first dose of study
Clinical Cures in the Per Protocol Clinically Evaluable Population
Investigators evaluated subjects for a clinical response of cure, failure, or indeterminate. Cure: Improvement or return to preinfection state or lack of progression of all pulmonary infiltrates, and resolution of all signs/symptoms present at enrollment. Failure: Persistence or worsening of signs/symptoms, the need for additional antibiotic, new pulmonary infection, progression of the chest radiograph, or death due to pneumonia. Indeterminate: Evaluation was not possible (lost to follow up, adverse event, major protocol violation). Indeterminates default to failure for analysis.
Test of Cure Visit, defined as 14-22 days after the first dose of study

Secondary Outcomes (2)

Bacteriologic Cures in the Intent to Treat Population
Test of Cure Visit, defined as 14-22 days after the first dose of study
Bacteriologic Cures in the Per Protocol Clinically Evaluable Population
Test of Cure Visit, defined as 14-22 days after the first dose of study

Study Arms (2)

Cethromycin

EXPERIMENTAL

Drug: Cethromycin

Clarithromycin

ACTIVE COMPARATOR

Drug: Clarithromycin

Interventions

CethromycinDRUG

Cethromycin 300 mg once per day (QD) for 7 days, administered orally

Also known as: Restanza, ABT-773

Cethromycin

ClarithromycinDRUG

Clarithromycin 250 mg twice per day (BID) for 7 days, administered orally

Also known as: Biaxin, Klacid, Klaracid

Clarithromycin

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Ambulatory male or female, 18 years of age or older
If female, non-lactating and at no risk or pregnancy (post-menopausal or must use adequate birth control)
Positive Chest X-ray consistent with diagnosis of bacterial pneumonia
Must be a suitable candidate for oral antibiotic therapy and must be able to swallow capsules intact
Recent history of respiratory illness consistent with the clinical signs and symptoms of bacterial CAP
Must be able to produce sputum

You may not qualify if:

Prior hospitalization within previous 4 weeks
Residence at a chronic care facility
Treatment with long-acting antimicrobial agents within the last 4 weeks, treatment with ceftriaxone, azithromycin or dirithromycin antibiotic within the last 7 days, or subjects who have received more than 24 hours of treatment with other antibiotics within 7 days prior to study drug administration
Any infection which requires the use of a concomitant antimicrobial agent
History of hypersensitivity or allergic reactions to macrolide, ketolide, quinolone, azalide or streptogramin antimicrobials
Treatment with another investigational drug within the last 4 weeks
Females who are pregnant or lactating
Subjects with known significant renal or hepatic impairment or disease
Subjects with a history of impaired renal function
Evidence of uncontrolled clinically significant cardiovascular, pulmonary, metabolic, gastrointestinal, neurological or endocrine disease, malignancy, or other abnormality (other than the disease being studied)
Subjects who would require parenteral antimicrobial therapy for the treatment of pneumonia
Any underlying disease or condition that would interfere with the completion of the study procedures and evaluations or absorption of the study drug
Currently receiving or are likely to require any of the following medications during the period between 2 weeks prior to Evaluation 1 and within 24 hours after the last dose of study drug: astemizol (Hismanal®) or pimozide (Orap®)
Currently receiving or are likely to require any of the following during the period from Evaluation 1 and within 24 hours after the last dose of study drug: theophylline or theophylline analogues (unless adequately monitored), carbamazepine, dexamethasone, phenobarbital, phenytoin, St. John's Wort, lamotrigine, troglitazone, warfarin and digitalis glycoside. Other barbiturates may be used with careful monitoring
Subjects who are currently receiving or who are likely to require any of the following medications during the period between Evaluation 1 and 4: other systemic antibiotic therapy, rifampin or rifabutin
+4 more criteria

Contact the study team to confirm eligibility.