Clinical trial NCT00251849: PROVIDENCE-1: Study of Rifalazil in Chlamydia Pneumoniae Seropositive Patients
Official title: Prospective Evaluation of Rifalazil Effect On Vascular Symptoms of Intermittent Claudication and Other Endpoints in Chlamydia Seropositive Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Peripheral Vascular Diseases
Intermittent Claudication
Keywords: Intermittent Claudication
Lead sponsor: ActivBiotics
Sponsor class: INDUSTRY
First posted: 2005-11-11
Enrollment: 274
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to determine whether rifalazil can significantly increase peak walking time (PWT) in patients with peripheral arterial disease (PAD).


Eligibility criteria: Inclusion Criteria:

* Male or female patients between 40 and 80 years of age, inclusive.
* 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 critical limb ischemia as evidenced by ischemic rest pain, ulceration, or gangrene.
* 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.

Primary outcomes:
measure: The efficacy endpoint is change from baseline in PWT
measure: The safety endpoints are adverse event rates, rates of clinically significant laboratory abnormalities, vital signs, and physical exam abnormalities, rate of vascular death, myocardial infarction (MI), stroke, revascularization or vascular procedures
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Scottsdale Cardiovascular Research Institute
state: Arizona
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
city: San Diego
country: United States
facility: Siddeg, Inc.
state: California
city: Santa Ana
country: United States
facility: Apex Research Institute
state: California
city: Santa Rosa
country: United States
facility: Radiant Research
state: California
city: Denver
country: United States
facility: Aurora Denver Cardiology Associates
state: Colorado
city: Clearwater
country: United States
facility: Tampa Bay Medical Research, Inc.
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Pembrook Pines
country: United States
facility: University Clinical Research
state: Florida
city: Sarasota
country: United States
facility: Cardiovascular Center of Sarasota
state: Florida
city: Conyers
country: United States
facility: Rockdale Medical Research Associates
state: Georgia
city: Indianapolis
country: United States
facility: The Care Group
state: Indiana
city: Auburn
country: United States
facility: Androscoggin Cardiology Associates
state: Maine
city: Worcester
country: United States
facility: University of Massachusetts Medical Center
state: Massachusetts
city: St. Louis
country: United States
facility: St. Louis University
state: Missouri
city: Durham
country: United States
facility: Durham VA Medical Center
state: North Carolina
city: Portland
country: United States
facility: New Hope Research of Oregon, Inc.
state: Oregon
city: Philadelphia
country: United States
facility: Radiant Research
state: Pennsylvania
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Rapid City
country: United States
facility: Black Hills Clinical Research Center
state: South Dakota
city: Norfolk
country: United States
facility: Hampton Roads Center for Clinical Research
state: Virginia
city: Richmond
country: United States
facility: National Clinical Research
state: Virginia
city: Wausau
country: United States
facility: Care Foundation
state: Wisconsin
city: Santo Andre
country: Brazil
facility: Hospital e Maternidade Dr. Christovao da Gama
state: SP
city: Sorocaba
country: Brazil
facility: Centro de Ciencias Medicas e Biologicas da Pontificia Universidade
state: SP
city: Botucatu
country: Brazil
facility: Depto de Cirurgia e ortopedia
city: Brasilia
country: Brazil
facility: SMHS - Area Especial
city: Rio de Janeiro
country: Brazil
facility: Hospital Pedro Ernesto
city: Sao Jose do Rio Preto
country: Brazil
facility: Instituto de molestias cardiovasculares
city: Moscow
country: Russian Federation
facility: Vishnevsky Institute of Surgery
city: Moscow
country: Russian Federation
facility: Russian State Medical University
city: Moscow
country: Russian Federation
facility: Russian State Medical University
city: Moscow
country: Russian Federation
facility: Central Clinical Hospital #1
city: Nizhniy Novgorod
country: Russian Federation
facility: City Hospital # 13
city: Novosibirsk
country: Russian Federation
facility: Meshalkin Research Institute of Blood Circulation Pathology
city: Saint Petersburg
country: Russian Federation
facility: Saint Petersburg Djanelidze Research Institute of First Aid
city: Saint Petersburg
country: Russian Federation
facility: Saint Petersburg State Medical Pediatric Academy
city: Saint Petersburg
country: Russian Federation
facility: Research Institute of Cardiology n.a. Almazov
city: Saint Petersburg
country: Russian Federation
facility: City Hospital #26
city: Saint Petersburg
country: Russian Federation
facility: Saint Petersburg Pavlov Medical University
city: Saint-Petersburg
country: Russian Federation
facility: City Hospital #2
city: Saint-Petersburg
country: Russian Federation
facility: Pokrovskaya Hospital
city: Saratov
country: Russian Federation
facility: City Clinical Hospital # 1
city: Smolensk
country: Russian Federation
facility: Clinical Hospital #1
city: St. Petersburg
country: Russian Federation
facility: Dzhanelidze Emergency Medicine Research Institutes
city: Tomsk
country: Russian Federation
facility: Tomsk Research Center
city: Vladimir
country: Russian Federation
facility: Regional Clinical Hospital
city: Volgograd
country: Russian Federation
facility: Clinical City Hospital # 25
Study officials:
References:
citation: 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.