PneumoniaPhase 3NCT00336544

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

A Phase 3 study testing Cethromycin and Clarithromycin in people with Pneumonia, run by Advanced Life Sciences, Inc. at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pneumonia
What is being tested?: Cethromycin and Clarithromycin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 522 participants
Where: 13 sitesUnited States
Study dates: Jun 2006to May 2007
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Prior hospitalization within previous 4 weeks
Residence at a chronic care facility
Active tuberculosis (or other mycobacterial infection, empyema, lung abscess, pulmonary embolism, pulmonary edema, cystic fibrosis, tumor (primary or metastatic) involving the lung, bronchial obstruction, a history of post-obstructive pneumonia (Chronic Obstructive Pulmonary Disease [COPD] is not exclusionary), known or suspected Pneumocystis carinii pneumonia
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

Show all 20Show fewer

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
Immunocompromised subjects, subjects receiving immunosuppressive agents, subjects with known human immunodeficiency virus (HIV) infections and history of acquired immune deficiency syndrome (AIDS) defining conditions or CD4+ T-lymphocyte count <200.
Subject with known or suspected central nervous system (CNS) disorder that predisposes them to seizures/lower seizure threshold (e.g., severe cerebral arteriosclerosis, epilepsy)
Previous treatment with cethromycin
Subjects with signs of septic shock (e.g., mental confusion, severe hypoxemia, severe hypotension, any other condition requiring intensive care unit [ICU] admission)

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

United States13 sites

ARGENTINA - Advanced Life Sciences
Woodridge, Illinois, 60517
BULGARIA - Advanced Life Sciences
Woodridge, Illinois, 60517
CHILE - Advanced Life Sciences
Woodridge, Illinois, 60517
CROATIA - Advanced Life Sciences
Woodridge, Illinois, 60517
ESTONIA - Advanced Life Sciences
Woodridge, Illinois, 60517
GERMANY - Advanced Life Sciences
Woodridge, Illinois, 60517
HUNGARY - Advanced Life Sciences
Woodridge, Illinois, 60517
ISRAEL - Advanced Life Sciences
Woodridge, Illinois, 60517
PERU - Advanced Life Sciences
Woodridge, Illinois, 60517
POLAND - Advanced Life Sciences
Woodridge, Illinois, 60517
ROMANIA - Advanced Life Sciences
Woodridge, Illinois, 60517
THE NETHERLANDS - Advanced Life Sciences
Woodridge, Illinois, 60517
UKRAINE - Advanced Life Sciences
Woodridge, Illinois, 60517

Other trials in United States

About this study

Official title: 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

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).

Read the detailed description

Lower respiratory tract infections remain one of the leading causes of death worldwide. Increasing rates of antibiotic resistance and newer, more pervasive pneumonia-causative pathogens contribute to this statistic. Currently available macrolide antibiotics for the treatment of community-acquired pneumonia are slowly losing effectiveness, resulting in the need to develop newer drugs to fight resistant infections. In this study, we compare the safety and efficacy of a common macrolide, clarithromycin, to a new ketolide, cethromycin.

Conditions: Pneumonia
Being tested: Cethromycin, Clarithromycin
Keywords: Pneumonia, Respiratory, Infection, Infectious, Advanced, Life, Sciences, Lung, Pulmonary, Cethromycin, Clarithromycin, Biaxin
Medical subject headings: Pneumonia, Infections, Communicable Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CethromycinDrug
Also called Restanza, ABT-773
Cethromycin 300 mg once per day (QD) for 7 days, administered orally
ClarithromycinDrug
Also called Biaxin, Klacid, Klaracid
Clarithromycin 250 mg twice per day (BID) for 7 days, administered orally

Study groups in NCT00336544
Study group	Role	What they receive
Cethromycin	Experimental	Not described Receives: Drug: Cethromycin
Clarithromycin	Active comparator	Not described Receives: Drug: Clarithromycin

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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
All bacteriologically evaluable subjects (ie., the subject had at least one, protocol-defined evaluable pathogen) who demonstrated eradication of all evaluable pathogens (S. pneumoniae, S. aureus, H. influenzae, M. catarrhalis, M. pneumoniae, C. pneumoniae, L. pneumophila).
Measured: Test of Cure Visit, defined as 14-22 days after the first dose of study
Bacteriologic Cures in the Per Protocol Clinically Evaluable Population
All bacteriologically evaluable subjects (ie., the subject had at least one, protocol-defined evaluable pathogen) who demonstrated eradication of all evaluable pathogens (S. pneumoniae, S. aureus, H. influenzae, M. catarrhalis, M. pneumoniae, C. pneumoniae, L. pneumophila).
Measured: Test of Cure Visit, defined as 14-22 days after the first dose of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2006May 2007

First posted13 Jun 2006 (estimated)
Study startJun 2006
Primary completionMay 2007
Study completionMay 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PneumoniaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 522 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00336544
Sponsor's protocol ID: CL06-001
Status last verified: Jan 2010
First submitted: 9 Jun 2006
Last updated: 26 Feb 2010
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection

All Pneumonia trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT00336544
Acronym / sponsor ID: CL06-001
Conditions: Pneumonia
Keywords: Pneumonia, Respiratory, Infection, Infectious, Advanced, Life, Sciences, Lung
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 522 participants (actual)
Lead sponsor: Advanced Life Sciences, Inc.Industry (pharma, biotech, devices)
Study start: Jun 2006
Primary completion: May 2007 (actual)
Study completion: May 2007 (actual)
First posted: 13 Jun 2006 (estimated)
Results: Posted 26 Feb 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Cethromycin	Experimental	Drug: Cethromycin
Clarithromycin	Active comparator	Drug: Clarithromycin

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (20 listed)

Prior hospitalization within previous 4 weeks
Residence at a chronic care facility
Active tuberculosis (or other mycobacterial infection, empyema, lung abscess, pulmonary embolism, pulmonary edema, cystic fibrosis, tumor (primary or metastatic) involving the lung, bronchial obstruction, a history of post-obstructive pneumonia (Chronic Obstructive Pulmonary Disease [COPD] is not exclusionary), known or suspected Pneumocystis carinii pneumonia
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CethromycinAlso: Restanza, ABT-773Cethromycin 300 mg once per day (QD) for 7 days, administered orally	Drug	Cethromycin
ClarithromycinAlso: Biaxin, Klacid, KlaracidClarithromycin 250 mg twice per day (BID) for 7 days, administered orally	Drug	Clarithromycin

Primary outcome

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

2 secondary outcomes

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

Results and safety

Results posted to the registry on 26 Feb 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cethromycin	261	242
Clarithromycin	260	238

Primary outcome: Clinical Cures in the Intent to Treat Population

Time frame: Test of Cure Visit, defined as 14-22 days after the first dose of study. Number. Unit: Participants

Measure	Cethromycin n = 257	Clarithromycin n = 253
Clinical Cures	213	224
Clinical Failures	21	9
Indeterminates	23	20

Cethromycin vs Clarithromycin: Mean Difference (Net): -5.7 (95% CI -11.9 to 0.6), p = 0.0769, Fisher Exact

Population analysed: The Intent to Treat Population is defined as all subjects with a confirmed diagnosis of community acquired pneumonia who took at least one dose of study medication. Subjects without a radiologist-confirmed chest X-ray for pneumonia were not included in the efficacy populations.

Primary outcome: Clinical Cures in the Per Protocol Clinically Evaluable Population

Time frame: Test of Cure Visit, defined as 14-22 days after the first dose of study. Number. Unit: Participants

Measure	Cethromycin n = 224	Clarithromycin n = 221
Clinical Cures	205	212
Clinical Failures	19	9

Cethromycin vs Clarithromycin: Mean Difference (Net): -4.4 (95% CI -9.1 to 0.3), p = 0.0775, Fisher Exact

Population analysed: The Per Protocol Clinically Evaluable Population included all ITT subjects who took the protocol-defined minimum therapy duration, were dosed with no other antimicrobials (unless allowed by protocol), and had no other major protocol violations

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Reported adverse events were recorded for 30 days after the last dose of study drug for individual subjects.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cethromycin	12 of 260 (4.6%)	77 of 260 (29.6%)	Not reported
Clarithromycin	9 of 257 (3.5%)	65 of 257 (25.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Pneumonia

Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David A. Eiznhamer, PhD. study director

Advanced Life Sciences

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cethromycin and Clarithromycin in people with Pneumonia, run by Advanced Life Sciences, Inc. at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Feb 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Cures in the Intent to Treat Population (time frame: Test of Cure Visit, defined as 14-22 days after the first dose of study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00336544.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2010.