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

Intermittent Claudication Clinical Trial

Official title:

Prospective Evaluation of Rifalazil Effect On Vascular Symptoms of Intermittent Claudication and Other Endpoints in Chlamydia Seropositive Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00251849
• Other study ID #: ABI-1648-022
• Status: Active, not recruiting
• Phase: Phase 3
• First received: November 9, 2005
• Last updated: August 20, 2008
• Start date: November 2005
• Est. completion date: December 2007

Study information

• Verified date: October 2006
• Source: ActivBiotics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 274
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intermittent Claudication
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Drug:
• Rifalazil

Locations

Country	Name	City	State
Brazil	Depto de Cirurgia e ortopedia	Botucatu
Brazil	SMHS - Area Especial	Brasilia
Brazil	Hospital Pedro Ernesto	Rio de Janeiro
Brazil	Hospital e Maternidade Dr. Christovao da Gama	Santo Andre	SP
Brazil	Instituto de molestias cardiovasculares	Sao Jose do Rio Preto
Brazil	Centro de Ciencias Medicas e Biologicas da Pontificia Universidade	Sorocaba	SP
Russian Federation	Central Clinical Hospital #1	Moscow
Russian Federation	Russian State Medical University	Moscow
Russian Federation	Russian State Medical University	Moscow
Russian Federation	Vishnevsky Institute of Surgery	Moscow
Russian Federation	City Hospital # 13	Nizhniy Novgorod
Russian Federation	Meshalkin Research Institute of Blood Circulation Pathology	Novosibirsk
Russian Federation	City Hospital #26	Saint Petersburg
Russian Federation	Research Institute of Cardiology n.a. Almazov	Saint Petersburg
Russian Federation	Saint Petersburg Djanelidze Research Institute of First Aid	Saint Petersburg
Russian Federation	Saint Petersburg Pavlov Medical University	Saint Petersburg
Russian Federation	Saint Petersburg State Medical Pediatric Academy	Saint Petersburg
Russian Federation	City Hospital #2	Saint-Petersburg
Russian Federation	Pokrovskaya Hospital	Saint-Petersburg
Russian Federation	City Clinical Hospital # 1	Saratov
Russian Federation	Clinical Hospital #1	Smolensk
Russian Federation	Dzhanelidze Emergency Medicine Research Institutes	St. Petersburg
Russian Federation	Tomsk Research Center	Tomsk
Russian Federation	Regional Clinical Hospital	Vladimir
Russian Federation	Clinical City Hospital # 25	Volgograd
United States	Androscoggin Cardiology Associates	Auburn	Maine
United States	Tampa Bay Medical Research, Inc.	Clearwater	Florida
United States	Rockdale Medical Research Associates	Conyers	Georgia
United States	Aurora Denver Cardiology Associates	Denver	Colorado
United States	Durham VA Medical Center	Durham	North Carolina
United States	The Care Group	Indianapolis	Indiana
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	Hampton Roads Center for Clinical Research	Norfolk	Virginia
United States	VA Palo Alto Health Care System	Palo Alto	California
United States	University Clinical Research	Pembrook Pines	Florida
United States	Radiant Research	Philadelphia	Pennsylvania
United States	New Hope Research of Oregon, Inc.	Portland	Oregon
United States	Black Hills Clinical Research Center	Rapid City	South Dakota
United States	National Clinical Research	Richmond	Virginia
United States	Siddeg, Inc.	San Diego	California
United States	Apex Research Institute	Santa Ana	California
United States	Radiant Research	Santa Rosa	California
United States	Cardiovascular Center of Sarasota	Sarasota	Florida
United States	Scottsdale Cardiovascular Research Institute	Scottsdale	Arizona
United States	St. Louis University	St. Louis	Missouri
United States	Omega Medical Research	Warwick	Rhode Island
United States	Care Foundation	Wausau	Wisconsin
United States	University of Massachusetts Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
ActivBiotics

Countries where clinical trial is conducted

United States,  Brazil,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The efficacy endpoint is change from baseline in PWT
Primary	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