PROVIDENCE-1: Study of Rifalazil in Chlamydia Pneumoniae Seropositive Patients
NCT ID: NCT00251849
Last Updated: 2008-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
274 participants
INTERVENTIONAL
2005-11-30
2007-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Rifalazil
Eligibility Criteria
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Inclusion Criteria
* The patient has seropositive evidence of Chlamydia pneumoniae defined by immunoglobulin G antibody titers.
* The patient has a diagnosis of intermittent claudication due to PAD at screening.
* The patient's maximal effort PWT is limited only by severe claudication symptoms.
* If the patient is taking cilostazol or pentoxifylline and has been on a stable dose of the medication for at least 6 months prior to screening. Patients who have recently discontinued medications for PAD and/or intermittent claudication must "wash-out" for at least one month prior to screening.
* The patient has been on a stable dose of statin therapy for at least 6 months prior to screening.Patients who have recently discontinued statin therapy must "wash-out" for at least one month prior to screening.
* Male and female patients must agree to use an effective form of birth control throughout the study period.
Exclusion Criteria
* The patient has had a major amputation of the leg or any other amputation that limits walking ability.
* The patient is planned for surgical/endovascular intervention for PAD during the course of the study.
* The patient has or is being treated or evaluated for tuberculosis.
* The patient has a known immunodeficient state (e.g., positive for human immunodeficiency virus) or is being treated with immunosuppressive drugs including high dose steroids or cyclosporine.
* The patient has an active infection requiring systemic or oral antibiotics.
* The patient has an uncontrolled, unstable or recently diagnosed autoimmune disease, including but not limited to systemic lupus, inflammatory bowel disease, sarcoidosis, rheumatoid arthritis, or psoriasis. Patients who develop autoimmune disease during the course of the study must be withdrawn.
* The patient's PWT is limited by symptoms other than claudication (shortness of breath, fatigue, angina, or arthritis).
* The patient has a history of alcohol abuse, illicit drug use or drug abuse or significant mental illness.
* The patient has a known or suspected allergy to the study medication(s) or class of study medication (rifamycins) to be administered.
* The patient chronically uses antibacterials or has previously received rifalazil or any rifamycin (e.g. rifampin).
* The patient has uncontrolled hypertension (resting blood pressure \> 160/100 mm Hg), uncontrolled moderate to severe congestive heart failure (CHF), or uncontrolled arrhythmic disorders.
40 Years
80 Years
ALL
No
Sponsors
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ActivBiotics
INDUSTRY
Locations
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Scottsdale Cardiovascular Research Institute
Scottsdale, Arizona, United States
VA Palo Alto Health Care System
Palo Alto, California, United States
Siddeg, Inc.
San Diego, California, United States
Apex Research Institute
Santa Ana, California, United States
Radiant Research
Santa Rosa, California, United States
Aurora Denver Cardiology Associates
Denver, Colorado, United States
Tampa Bay Medical Research, Inc.
Clearwater, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
University Clinical Research
Pembrook Pines, Florida, United States
Cardiovascular Center of Sarasota
Sarasota, Florida, United States
Rockdale Medical Research Associates
Conyers, Georgia, United States
The Care Group
Indianapolis, Indiana, United States
Androscoggin Cardiology Associates
Auburn, Maine, United States
University of Massachusetts Medical Center
Worcester, Massachusetts, United States
St. Louis University
St Louis, Missouri, United States
Durham VA Medical Center
Durham, North Carolina, United States
New Hope Research of Oregon, Inc.
Portland, Oregon, United States
Radiant Research
Philadelphia, Pennsylvania, United States
Omega Medical Research
Warwick, Rhode Island, United States
Black Hills Clinical Research Center
Rapid City, South Dakota, United States
Hampton Roads Center for Clinical Research
Norfolk, Virginia, United States
National Clinical Research
Richmond, Virginia, United States
Care Foundation
Wausau, Wisconsin, United States
Hospital e Maternidade Dr. Christovao da Gama
Santo André, São Paulo, Brazil
Centro de Ciencias Medicas e Biologicas da Pontificia Universidade
Sorocaba, São Paulo, Brazil
Depto de Cirurgia e ortopedia
Botucatu, , Brazil
SMHS - Area Especial
Brasília, , Brazil
Hospital Pedro Ernesto
Rio de Janeiro, , Brazil
Instituto de molestias cardiovasculares
São José do Rio Preto, , Brazil
Vishnevsky Institute of Surgery
Moscow, , Russia
Russian State Medical University
Moscow, , Russia
Russian State Medical University
Moscow, , Russia
Central Clinical Hospital #1
Moscow, , Russia
City Hospital # 13
Nizhny Novgorod, , Russia
Meshalkin Research Institute of Blood Circulation Pathology
Novosibirsk, , Russia
Dzhanelidze Emergency Medicine Research Institutes
Saint Petersburg, , Russia
Saint Petersburg Djanelidze Research Institute of First Aid
Saint Petersburg, , Russia
Saint Petersburg State Medical Pediatric Academy
Saint Petersburg, , Russia
Research Institute of Cardiology n.a. Almazov
Saint Petersburg, , Russia
City Hospital #2
Saint Petersburg, , Russia
City Hospital #26
Saint Petersburg, , Russia
Saint Petersburg Pavlov Medical University
Saint Petersburg, , Russia
Pokrovskaya Hospital
Saint Petersburg, , Russia
City Clinical Hospital # 1
Saratov, , Russia
Clinical Hospital #1
Smolensk, , Russia
Tomsk Research Center
Tomsk, , Russia
Regional Clinical Hospital
Vladimir, , Russia
Clinical City Hospital # 25
Volgograd, , Russia
Countries
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References
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Jaff MR, Dale RA, Creager MA, Lipicky RJ, Constant J, Campbell LA, Hiatt WR. Anti-chlamydial antibiotic therapy for symptom improvement in peripheral artery disease: prospective evaluation of rifalazil effect on vascular symptoms of intermittent claudication and other endpoints in Chlamydia pneumoniae seropositive patients (PROVIDENCE-1). Circulation. 2009 Jan 27;119(3):452-8. doi: 10.1161/CIRCULATIONAHA.108.815308. Epub 2009 Jan 12.
Other Identifiers
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ABI-1648-022
Identifier Type: -
Identifier Source: org_study_id