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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00251849
Recruitment Status : Unknown
Verified October 2006 by ActivBiotics.
Recruitment status was:  Active, not recruiting
First Posted : November 11, 2005
Last Update Posted : August 21, 2008
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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).

Condition or disease Intervention/treatment Phase
Peripheral Vascular Diseases Intermittent Claudication Drug: Rifalazil Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 274 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Prospective Evaluation of Rifalazil Effect On Vascular Symptoms of Intermittent Claudication and Other Endpoints in Chlamydia Seropositive Patients
Study Start Date : November 2005
Estimated Study Completion Date : December 2007

Primary Outcome Measures :
  1. The efficacy endpoint is change from baseline in PWT
  2. 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

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00251849

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Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00251849     History of Changes
Other Study ID Numbers: ABI-1648-022
First Posted: November 11, 2005    Key Record Dates
Last Update Posted: August 21, 2008
Last Verified: October 2006

Keywords provided by ActivBiotics:
Intermittent Claudication

Additional relevant MeSH terms:
Vascular Diseases
Intermittent Claudication
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Arterial Occlusive Diseases
Signs and Symptoms
KRM 1648
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Leprostatic Agents