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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2006 by ActivBiotics.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
ActivBiotics
ClinicalTrials.gov Identifier:
NCT00251849
First received: November 9, 2005
Last updated: August 20, 2008
Last verified: October 2006
  Purpose

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 Intervention Phase
Peripheral Vascular Diseases
Intermittent Claudication
Drug: Rifalazil
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Prospective Evaluation of Rifalazil Effect On Vascular Symptoms of Intermittent Claudication and Other Endpoints in Chlamydia Seropositive Patients

Resource links provided by NLM:


Further study details as provided by ActivBiotics:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 274
Study Start Date: November 2005
Estimated Study Completion Date: December 2007
  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00251849

  Show 48 Study Locations
Sponsors and Collaborators
ActivBiotics
  More Information

No publications provided by ActivBiotics

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00251849     History of Changes
Other Study ID Numbers: ABI-1648-022
Study First Received: November 9, 2005
Last Updated: August 20, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by ActivBiotics:
Intermittent Claudication

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

ClinicalTrials.gov processed this record on July 20, 2014