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

August 20, 2008 updated by: ActivBiotics

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

274

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Botucatu, Brazil, 18618-970
        • Depto de Cirurgia e ortopedia
      • Brasilia, Brazil, 70330-150
        • SMHS - Area Especial
      • Rio de Janeiro, Brazil
        • Hospital Pedro Ernesto
      • Sao Jose do Rio Preto, Brazil, 15015-210
        • Instituto de Molestias Cardiovasculares
    • SP
      • Santo Andre, SP, Brazil, 09030-010
        • Hospital e Maternidade Dr. Christóvão da Gama
      • Sorocaba, SP, Brazil, 18031-000
        • Centro de Ciencias Medicas e Biologicas da Pontificia Universidade
  • Russian Federation
      • Moscow, Russian Federation, 125367
        • Central Clinical Hospital #1
      • Moscow, Russian Federation, 113093
        • Vishnevsky Institute of Surgery
      • Moscow, Russian Federation, 115516
        • Russian State Medical University
      • Moscow, Russian Federation, 117049
        • Russian State Medical University
      • Nizhniy Novgorod, Russian Federation, 603018
        • City Hospital # 13
      • Novosibirsk, Russian Federation, 630055
        • Meshalkin Research Institute of Blood Circulation Pathology
      • Saint Petersburg, Russian Federation, 192242
        • Saint Petersburg Djanelidze Research Institute of First Aid
      • Saint Petersburg, Russian Federation, 194100
        • Saint Petersburg State Medical Pediatric Academy
      • Saint Petersburg, Russian Federation, 194156
        • Research Institute of Cardiology n.a. Almazov
      • Saint Petersburg, Russian Federation, 196247
        • City Hospital #26
      • Saint Petersburg, Russian Federation, 197022
        • Saint Petersburg Pavlov Medical University
      • Saint-Petersburg, Russian Federation, 194354
        • City Hospital #2
      • Saint-Petersburg, Russian Federation, 199106
        • Pokrovskaya hospital
      • Saratov, Russian Federation, 410017
        • City Clinical Hospital # 1
      • Smolensk, Russian Federation, 214000
        • Clinical hospital #1
      • St. Petersburg, Russian Federation, 192242
        • Dzhanelidze Emergency Medicine Research Institutes
      • Tomsk, Russian Federation, 643012
        • Tomsk Research Center
      • Vladimir, Russian Federation, 600023
        • Regional Clinical Hospital
      • Volgograd, Russian Federation, 400138
        • Clinical City Hospital # 25
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85251
        • Scottsdale Cardiovascular Research Institute
    • California
      • Palo Alto, California, United States, 94304
        • VA Palo Alto Health Care System
      • San Diego, California, United States, 92103
        • Siddeg, Inc.
      • Santa Ana, California, United States, 92705
        • Apex Research Institute
      • Santa Rosa, California, United States, 95405
        • Radiant Research
    • Colorado
      • Denver, Colorado, United States, 80218
        • Aurora Denver Cardiology Associates
    • Florida
      • Clearwater, Florida, United States, 33761
        • Tampa Bay Medical Research, Inc.
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Center for Clinical Research
      • Pembrook Pines, Florida, United States, 33024
        • University Clinical Research
      • Sarasota, Florida, United States, 34239
        • Cardiovascular Center of Sarasota
    • Georgia
      • Conyers, Georgia, United States, 30094
        • Rockdale Medical Research Associates
    • Indiana
      • Indianapolis, Indiana, United States, 46290
        • The Care Group
    • Maine
      • Auburn, Maine, United States, 04210
        • Androscoggin Cardiology Associates
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Medical Center
    • Missouri
      • St. Louis, Missouri, United States, 63104
        • St. Louis University
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Durham VA Medical Center
    • Oregon
      • Portland, Oregon, United States, 97219
        • New Hope Research of Oregon, Inc.
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19115
        • Radiant Research
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Omega Medical Research
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Black Hills Clinical Research Center
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Hampton Roads Center for Clinical Research
      • Richmond, Virginia, United States, 23294
        • National Clinical Research
    • Wisconsin
      • Wausau, Wisconsin, United States, 54401
        • Care Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ActivBiotics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Study Completion

December 1, 2007

Study Registration Dates

First Submitted

November 9, 2005

First Submitted That Met QC Criteria

November 9, 2005

First Posted (Estimate)

November 11, 2005

Study Record Updates

Last Update Posted (Estimate)

August 21, 2008

Last Update Submitted That Met QC Criteria

August 20, 2008

Last Verified

October 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABI-1648-022

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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