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Respiratory Tract InfectionsPhase 4KEYSNCT00132951

KEYS: Study Comparing Clinical Health Outcomes of Telithromycin Versus Azithromycin in Outpatients With Community-acquired Lower Respiratory Tract Infections

A Phase 4 study testing Telithromycin and Azithromycin in people with Respiratory Tract Infections and Chronic Bronchitis, run by Sanofi at 2 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to determine if 1 course of antibiotic treatment with telithromycin is superior to azithromycin in the treatment of lower respiratory tract infections (LRTIs), acute exacerbations of chronic bronchitis (AECBs) and community-acquired pneumonia (CAP) in the community setting. Read more about this study

Who is it for?
Ages 18 to 35 years
What is being tested?
Telithromycin and Azithromycin
Type of treatment
Pill or oral medicine
How many people
2,051 participants
Where
2 sitesin 2 countries
Study dates
Oct 2004to Sep 2006
Phase
Phase 4
Are there results?
None posted in the registry

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 to 35 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Subjects meeting all of the following criteria will be considered for enrollment into the study:
  • Male and female adult outpatient subjects diagnosed with AECB or CAP
  • Female subjects must be either postmenopausal for ≥ 1 year or surgically incapable of bearing children. Women of childbearing potential must have a normal menstrual flow ≤ 1 month before study entry, a negative serum pregnancy test immediately prior to study entry, and meet the criteria for acceptable birth control.
  • Informed consent must be obtained in writing for all subjects upon enrollment.
  • Subjects will have a diagnosis of AECB or CAP, as defined below.
  • AECB-Specific Inclusion Criteria:
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  • Subjects greater than or equal to 35 years of age
  • Subjects with a documented history of chronic bronchitis: with a basal forced expiratory volume in one second (FEV1) < 70% and > 35%; who have had at least one or more AECB in the previous year; and with FEV1/forced vital capacity (FVC) < 70%.
  • Subjects with a clinical diagnosis of AECB, presumed to be due to bacterial infection based on increased sputum purulence with either increased dyspnea or sputum volume
  • Subjects producing spontaneous sputum
  • Subjects with a ≥ 10 pack-year history of cigarette smoking
  • CAP-Specific Inclusion Criteria:
  • Fever (oral temperature > 38°C [100.4°F] or tympanic temperature > 38.5°C [101.2°F] or rectal temperature > 39°C [102.2°F])
  • Chills
  • Pleuritic chest pain
  • Cough
  • Spontaneous production of purulent sputum or a change in sputum character
  • Auscultatory findings (such as rales [also known as crepitations] and/or evidence of pulmonary consolidation [ie, dullness on percussion, bronchial breath sounds, egophony])
  • Subjects greater than or equal to 18 years of age
  • Chest x-ray findings that support a clinical diagnosis of bacterial pneumonia (eg, presence of presumably new infiltrate[s])
  • Subjects with a clinical diagnosis of mild to moderate CAP due to bacterial infection based on at least 1 of the following signs and symptoms of CAP:
  • In addition, subjects with a clinical diagnosis of CAP will have at least 1 of the following signs and symptoms of CAP:
  • Dyspnea or tachypnea (particularly if progressive in nature)

Who cannot join

  • Subjects presenting with any of the following will not be included in the study:
  • Subjects with a known history of congenital long-QTc syndrome
  • Subjects who are pregnant or breast-feeding
  • Subjects who have hypersensitivity to telithromycin, azithromycin, or the macrolide classes of antibiotics
  • Subjects who require or receive treatment with rifampin (Rifadin), phenytoin (Dilantin), carbamazepine (Carbatrol, Tegretol), phenobarbital, or St. John's wort (herbal supplement) within 2 weeks prior to Visit 1 or during the study
  • Subjects who require treatment during the study with ergot alkaloid derivatives, cisapride (Propulsid), pimozide (Orap), bromocriptine, cabergoline (Dostinex), or pergolide (Permax)
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  • Subjects who have previously participated in this study
  • Subjects with a previous history of myasthenia gravis
  • Subjects with current acute respiratory failure or subjects who require aggressive airway management
  • Hospitalized subjects and subjects from institutional care facilities
  • Subjects who have been treated with oral or parenteral antibiotics within 14 days prior to enrollment or who plan to take antibiotics other than study drug during the treatment period
  • Subjects who are receiving other medications, including systemic antimicrobial agents, or who have other disease conditions or infections that could interfere with the evaluation of drug efficacy or safety
  • Subjects with a concomitant condition (including clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease) that makes either implementation of the protocol or interpretation of the study results difficult
  • Subjects with a progressively fatal disease or life expectancy of < 3 months
  • Subjects who have received any other investigational drug or device within 1 month prior to study entry, or who have such treatment planned during the study period
  • Subjects with a recent (within 3 months) history of drug or alcohol abuse
  • Immunocompromised subjects, including but not limited to subjects with: known human immunodeficiency virus infection (CD4 count < 200/mm3); known neutropenia (< 1500 neutrophils/mm3); chronic corticosteroid therapy (≥ 10 mg/day prednisolone therapy or equivalent for at least the past 3 months); immunosuppressant treatment, other than corticosteroids, within the previous 6 months; splenectomized subjects or subjects with known hyposplenia or asplenia.
  • Subjects with mental conditions that render them unable to understand the nature, scope, and possible consequences of the study
  • Subjects who are unlikely to comply with the protocol (eg, have an uncooperative attitude, an inability to return for follow-up visits, or are unlikely to complete the study)
  • Subjects who have known impaired hepatic function
  • Subjects who have known impaired renal function
  • AECB-Specific Exclusion Criteria:
  • Subjects with acute bronchitis
  • Subjects with a known diagnosis of bronchiectasis; cystic fibrosis; lung cancer or lung metastases; or active pulmonary tuberculosis.
  • CAP-Specific Exclusion Criteria:
  • Subjects with severe pneumonia (as defined by the investigator's clinical judgment)
  • Subjects with CAP symptoms that require parenteral antibiotic treatment, such as 1 or more of the following conditions:
  • Respiratory frequency >30 breaths/minute
  • Chest x-ray showing an increase in the size of the opacity by ≥ 50% within 48 hours of the initial or current evaluation
  • Shock (systolic blood pressure < 90 mmHg or diastolic blood pressure < 60 mmHg)
  • Altered mental status (disorientation to person, place, or time that is not known to be chronic, lethargy, stupor, or coma)
  • < 90% O2 saturation (by pulse oximetry), or a PaO2 < 60 mmHg
  • Requires mechanical ventilation
  • Requires vasopressors for > 4 hours
  • Urine output < 20 mL/hr or total urine output < 80 mL in 4 hours, unless another explanation is available, or acute renal failure requiring dialysis
  • Hypothermia, defined as core body temperature of < 35°C (95°F)
  • The investigator and sponsor must approve any waiver of these inclusion and exclusion criteria on a case-by-case basis prior to enrolling a subject. Both the investigator and sponsor must document any waivers.
  • No subject will be allowed to enroll in this study more than once.
  • Subjects of Reproductive Potential:
  • Women of childbearing potential may participate in the study only if the following conditions are met:
  • Had a normal menstrual flow ≤ 1 month before study entry
  • Has a negative pregnancy test (serum β-subunit hCG) immediately before study entry (ie, before the start of treatment or any other study procedure that could potentially harm the fetus). If obtaining the serum pregnancy test result will cause a delay in treatment, a subject may be entered on the basis of a negative urine pregnancy test sensitive to at least 50 mU/mL, pending results of the serum pregnancy test. Subsequently, if the result of the serum test is positive, the subject must be discontinued from study drug, and every attempt must be made to follow such subjects to term.
  • Must agree to use an accepted method of contraception (ie, oral or implanted contraceptive with a barrier method; spermicide and barrier methods; or intrauterine device). The subject must agree to continue with the same method throughout the study.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • Sanofi-Aventis Administrative Office

    Bridgewater, New Jersey

Other trials in United States

Canada1 site

  • Sanofi-Aventis Administrative Office

    Québec

Other trials in Canada

About this study

Official title: A Randomized, Investigator Blinded, Multi-Center Clinical Study To Compare Patient Outcomes and Clinical Effectiveness of Telithromycin Versus Azithromycin in Outpatients With Lower Respiratory Tract Infections

The purpose of this study is to determine if 1 course of antibiotic treatment with telithromycin is superior to azithromycin in the treatment of lower respiratory tract infections (LRTIs), acute exacerbations of chronic bronchitis (AECBs) and community-acquired pneumonia (CAP) in the community setting.

Being tested
Telithromycin, Azithromycin
Medical subject headings
Respiratory Tract Infections, Bronchitis, Chronic, Pneumonia

What participants receive

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

  • TelithromycinDrug

    Also called Ketek

    Telithromycin (AECB: 2 tablets per day for Days 1-5; CAP: 2 tablets per day for Days 1-7)

  • AzithromycinDrug

    Azithromycin (AECB: 2 tablets on Day 1 then 1 tablet + 1 placebo tablet per day for Days 2-5; CAP: 2 tablets on Day 1 then 1 tablet + 1 placebo tablet per day for Days 2-5 then 2 placebo tablets per day for Days 6-7)

What is being measured

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

  1. Post-treatment utilization of healthcare resources, as assessed by unscheduled nonprotocol return office visits, emergency room (ER) visits, hospitalization, and additional nonprotocol antibiotic prescriptions in the 30 days following treatment.

    Measured: 18 months

Timeline

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

  1. First posted22 Aug 2005 (estimated)
  2. Study startOct 2004
  3. Primary completionSep 2006
  4. Study completionSep 2006

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
2,051 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00132951
Sponsor's protocol ID
HMR3647A_4019
Acronym
KEYS
Status last verified
Aug 2009
First submitted
18 Aug 2005
Last updated
27 Aug 2009
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Telithromycin and Azithromycin in people with Respiratory Tract Infections and Chronic Bronchitis, run by Sanofi at 2 sites in 2 countries.

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 23 inclusion and 43 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: stopped early, as of the sponsor's last update on 27 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Canada. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

The study was stopped early. Results are not available in the source record.

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?

Post-treatment utilization of healthcare resources, as assessed by unscheduled nonprotocol return office visits, emergency room (ER) visits, hospitalization, and additional nonprotocol antibiotic prescriptions in the 30 days following treatment. (time frame: 18 months). 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 NCT00132951.

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 27 Aug 2009.

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