PROVIDENCE-1: Study of Rifalazil in Chlamydia Pneumoniae Seropositive Patients

NCT00251849 | Unknown Phase 3

• 1 other identifier: ABI-1648-022
• Study Type: interventional
• Target: 274
• Locations: 3 countries
• Sites: 48

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).

Conditions

Peripheral Vascular Diseases; Intermittent Claudication

Keywords

Intermittent Claudication

Outcome Measures

Primary Outcomes (2)

• The efficacy endpoint is change from baseline in PWT

• 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

Interventions

Rifalazil DRUG

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ActivBiotics: lead

Study Sites (48)

Scottsdale Cardiovascular Research Institute

Scottsdale, Arizona, 85251, United States

Location

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

Location

Siddeg, Inc.

San Diego, California, 92103, United States

Location

Apex Research Institute

Santa Ana, California, 92705, United States

Location

Radiant Research

Santa Rosa, California, 95405, United States

Location

Aurora Denver Cardiology Associates

Denver, Colorado, 80218, United States

Location

Tampa Bay Medical Research, Inc.

Clearwater, Florida, 33761, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

University Clinical Research

Pembrook Pines, Florida, 33024, United States

Location

Cardiovascular Center of Sarasota

Sarasota, Florida, 34239, United States

Location

Rockdale Medical Research Associates

Conyers, Georgia, 30094, United States

Location

The Care Group

Indianapolis, Indiana, 46290, United States

Location

Androscoggin Cardiology Associates

Auburn, Maine, 04210, United States

Location

University of Massachusetts Medical Center

Worcester, Massachusetts, 01655, United States

Location

St. Louis University

St Louis, Missouri, 63104, United States

Location

Durham VA Medical Center

Durham, North Carolina, 27705, United States

Location

New Hope Research of Oregon, Inc.

Portland, Oregon, 97219, United States

Location

Radiant Research

Philadelphia, Pennsylvania, 19115, United States

Location

Omega Medical Research

Warwick, Rhode Island, 02886, United States

Location

Black Hills Clinical Research Center

Rapid City, South Dakota, 57701, United States

Location

Hampton Roads Center for Clinical Research

Norfolk, Virginia, 23502, United States

Location

National Clinical Research

Richmond, Virginia, 23294, United States

Location

Care Foundation

Wausau, Wisconsin, 54401, United States

Location

Hospital e Maternidade Dr. Christovao da Gama

Santo André, São Paulo, 09030-010, Brazil

Location

Centro de Ciencias Medicas e Biologicas da Pontificia Universidade

Sorocaba, São Paulo, 18031-000, Brazil

Location

Depto de Cirurgia e ortopedia

Botucatu, 18618-970, Brazil

Location

SMHS - Area Especial

Brasília, 70330-150, Brazil

Location

Hospital Pedro Ernesto

Rio de Janeiro, Brazil

Location

Instituto de molestias cardiovasculares

São José do Rio Preto, 15015-210, Brazil

Location

Vishnevsky Institute of Surgery

Moscow, 113093, Russia

Location

Russian State Medical University

Moscow, 115516, Russia

Location

Russian State Medical University

Moscow, 117049, Russia

Location

Central Clinical Hospital #1

Moscow, 125367, Russia

Location

City Hospital # 13

Nizhny Novgorod, 603018, Russia

Location

Meshalkin Research Institute of Blood Circulation Pathology

Novosibirsk, 630055, Russia

Location

Dzhanelidze Emergency Medicine Research Institutes

Saint Petersburg, 192242, Russia

Location

Saint Petersburg Djanelidze Research Institute of First Aid

Saint Petersburg, 192242, Russia

Location

Saint Petersburg State Medical Pediatric Academy

Saint Petersburg, 194100, Russia

Location

Research Institute of Cardiology n.a. Almazov

Saint Petersburg, 194156, Russia

Location

City Hospital #2

Saint Petersburg, 194354, Russia

Location

City Hospital #26

Saint Petersburg, 196247, Russia

Location

Saint Petersburg Pavlov Medical University

Saint Petersburg, 197022, Russia

Location

Pokrovskaya Hospital

Saint Petersburg, 199106, Russia

Location

City Clinical Hospital # 1

Saratov, 410017, Russia

Location

Clinical Hospital #1

Smolensk, 214000, Russia

Location

Tomsk Research Center

Tomsk, 643012, Russia

Location

Regional Clinical Hospital

Vladimir, 600023, Russia

Location

Clinical City Hospital # 25

Volgograd, 400138, Russia

Location

Related Publications (1)

• 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.

  PMID: 19139383 DERIVED

MeSH Terms

Conditions

Peripheral Vascular Diseases; Intermittent Claudication

Interventions

KRM 1648

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Peripheral Arterial Disease; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 9, 2005
• First Posted: November 11, 2005
• Study Start: November 1, 2005
• Study Completion: December 1, 2007
• Last Updated: August 21, 2008

Record last verified: 2006-10

Locations

BR (6); RU (19); US (23)