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Peripheral Vascular DiseasesPhase 3NCT00251849

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

A Phase 3 study testing Rifalazil in people with Peripheral Vascular Diseases and Intermittent Claudication, run by ActivBiotics at 48 sites in 3 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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). Read more about this study

Who is it for?
Ages 40 to 80 years
What is being tested?
Rifalazil
How many people
274 participants
Where
48 sitesin 3 countries
Study dates
Nov 2005to Dec 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.

Trial locations and contacts

48 sites in 3 countries.

48 sites in 3 countries

United States23 sites

  • Androscoggin Cardiology Associates

    Auburn, Maine, 04210

  • Tampa Bay Medical Research, Inc.

    Clearwater, Florida, 33761

  • Rockdale Medical Research Associates

    Conyers, Georgia, 30094

  • Aurora Denver Cardiology Associates

    Denver, Colorado, 80218

  • Durham VA Medical Center

    Durham, North Carolina, 27705

  • The Care Group

    Indianapolis, Indiana, 46290

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • Hampton Roads Center for Clinical Research

    Norfolk, Virginia, 23502

  • VA Palo Alto Health Care System

    Palo Alto, California, 94304

  • University Clinical Research

    Pembrook Pines, Florida, 33024

  • Radiant Research

    Philadelphia, Pennsylvania, 19115

  • New Hope Research of Oregon, Inc.

    Portland, Oregon, 97219

  • Black Hills Clinical Research Center

    Rapid City, South Dakota, 57701

  • National Clinical Research

    Richmond, Virginia, 23294

  • Siddeg, Inc.

    San Diego, California, 92103

  • Apex Research Institute

    Santa Ana, California, 92705

  • Radiant Research

    Santa Rosa, California, 95405

  • Cardiovascular Center of Sarasota

    Sarasota, Florida, 34239

  • Scottsdale Cardiovascular Research Institute

    Scottsdale, Arizona, 85251

  • St. Louis University

    St Louis, Missouri, 63104

  • Omega Medical Research

    Warwick, Rhode Island, 02886

  • Care Foundation

    Wausau, Wisconsin, 54401

  • University of Massachusetts Medical Center

    Worcester, Massachusetts, 01655

Other trials in United States

Russia19 sites

  • Vishnevsky Institute of Surgery

    Moscow, 113093

  • Russian State Medical University

    Moscow, 115516

  • Russian State Medical University

    Moscow, 117049

  • Central Clinical Hospital #1

    Moscow, 125367

  • City Hospital # 13

    Nizhny Novgorod, 603018

  • Meshalkin Research Institute of Blood Circulation Pathology

    Novosibirsk, 630055

  • Dzhanelidze Emergency Medicine Research Institutes

    Saint Petersburg, 192242

  • Saint Petersburg Djanelidze Research Institute of First Aid

    Saint Petersburg, 192242

  • Saint Petersburg State Medical Pediatric Academy

    Saint Petersburg, 194100

  • Research Institute of Cardiology n.a. Almazov

    Saint Petersburg, 194156

  • City Hospital #2

    Saint Petersburg, 194354

  • City Hospital #26

    Saint Petersburg, 196247

  • Saint Petersburg Pavlov Medical University

    Saint Petersburg, 197022

  • Pokrovskaya Hospital

    Saint Petersburg, 199106

  • City Clinical Hospital # 1

    Saratov, 410017

  • Clinical Hospital #1

    Smolensk, 214000

  • Tomsk Research Center

    Tomsk, 643012

  • Regional Clinical Hospital

    Vladimir, 600023

  • Clinical City Hospital # 25

    Volgograd, 400138

Other trials in Russia

Brazil6 sites

  • Depto de Cirurgia e ortopedia

    Botucatu, 18618-970

  • SMHS - Area Especial

    Brasília, 70330-150

  • Hospital Pedro Ernesto

    Rio de Janeiro

  • Hospital e Maternidade Dr. Christovao da Gama

    Santo André, São Paulo, 09030-010

  • Instituto de molestias cardiovasculares

    São José do Rio Preto, 15015-210

  • Centro de Ciencias Medicas e Biologicas da Pontificia Universidade

    Sorocaba, São Paulo, 18031-000

Other trials in Brazil

About this study

Official title: 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).

Being tested
Rifalazil
Keywords
Intermittent Claudication
Medical subject headings
Peripheral Vascular Diseases, Intermittent Claudication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RifalazilDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Nov 2005 (estimated)
  2. Study startNov 2005
  3. Study completionDec 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
274 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00251849
Sponsor's protocol ID
ABI-1648-022
Status last verified
Oct 2006
First submitted
9 Nov 2005
Last updated
21 Aug 2008
Results posted
No

Publications

  • 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.

    PubMed 19139383

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rifalazil in people with Peripheral Vascular Diseases and Intermittent Claudication, run by ActivBiotics at 48 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in United States, Russia, Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The efficacy endpoint is change from baseline in PWT. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00251849, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2008.

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