Antibiotic Treatment of Gulf War Veterans' Illnesses

This study has been completed.
Sponsor:
Collaborators:
Pfizer
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00007735
First received: December 29, 2000
Last updated: January 20, 2009
Last verified: February 2007
  Purpose

In 1990 and 1991, the U.S. deployed approximately 700,000 troops to the Persian Gulf to liberate Kuwait from Iraqi occupation. While there were few casualties associated with the Gulf War, many individuals returned from this conflict with unexplained symptoms and illnesses. This constellation of symptoms has been termed Gulf War Veterans' Illnesses (GWI). Although several explanations have been offered as to the cause of GWI, none of the putative etiologic agents or conditions is currently supported by sufficient evidence. One explanation that has received fairly widespread attention is systemic Mycoplasma fermentans infection. It is the purpose of this study to determine if antibiotic treatment directed against Mycoplasma species (i.e. doxycycline) will improve functioning and symptoms in deployed Gulf War veterans with GWI.


Condition Intervention Phase
Persian Gulf Syndrome
Mycoplasma Infections
Drug: Doxycycline (200mg/day) or Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Official Title: CSP #475 - Persian Gulf - Antibiotic Treatment Trial of Gulf War Veterans' Illnesses

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment: 450
Study Start Date: January 1999
Estimated Study Completion Date: October 2001
  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

All veterans deployed to the Gulf War between August, 1990 and August, 1991 having at least two of the following symptoms: Fatigue, musculoskeletal pain or neurocognitive dysfunction. Mycoplasma positive

  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: NCT00007735

  Hide Study Locations
Locations
United States, Alabama
Vamc - Birmingham, Al
Birmingham, Alabama, United States, 35233
United States, California
Naval Health Research Center Merchant Illness Divi
San Diego, California, United States, 92152
United States, District of Columbia
Uniformed Services University Department of Psychi
Washington, District of Columbia, United States, 20307-5001
United States, Georgia
Vamc - Augusta, Ga
Augusta, Georgia, United States, 30904-6285
United States, Illinois
Vamc - Hines,Il
Hines, Illinois, United States, 60141
United States, Louisiana
Vamc - New Orleans, La
New Orleans, Louisiana, United States, 70146
United States, Massachusetts
Vamc - Boston, Ma
Boston, Massachusetts, United States, 02130
United States, Nebraska
Vamc - Omaha, NE
Omaha, Nebraska, United States, 68105
United States, New Hampshire
Vamc - Manchester,Nh
Manchester, New Hampshire, United States, 03103
United States, New Jersey
Vamc - East Orange, Nj
East Orange, New Jersey, United States, 07018
United States, New Mexico
Vamc - Albuquerque, Nm
Albuquerque, New Mexico, United States, 87108
United States, New York
Vamc - Albany, Ny
Albany, New York, United States, 12208
Vamc - Bronx,Ny
Bronx, New York, United States, 10468
Vamc - Brooklyn, Ny
Brooklyn, New York, United States, 11209
United States, North Carolina
Vamc - Durham, Nc
Durham, North Carolina, United States, 27705
United States, North Dakota
Vamc - Fargo, Nd
Fargo, North Dakota, United States, 58102-2498
United States, Ohio
Vamc - Dayton, Oh
Kettering, Ohio, United States, 45429
United States, Oklahoma
Vamc - Oklahoma City, Ok
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Vamc - Philadelphia, Pa
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
Vamc - Providence, Ri
Providence, Rhode Island, United States, 02908-4799
United States, South Carolina
Vamc - Charleston, Sc
Charleston, South Carolina, United States, 29401-5799
United States, Tennessee
Vamc - Nashville, Tn
Nashville, Tennessee, United States, 37212-2637
United States, Texas
Vamc - Houston, Tx
Houston, Texas, United States, 77030-4298
United States, Vermont
Vamc - White River Junction
White River Junction, Vermont, United States, 05009
United States, Virginia
Vamc - Richmond, Va
Richmond, Virginia, United States, 23249
United States, Wisconsin
Vamc - Milwaukee, Wi
Milwaukee, Wisconsin, United States, 53295
Puerto Rico
Vamc - San Juan, Pr
San Juan, Puerto Rico, 00927
Sponsors and Collaborators
Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00007735     History of Changes
Other Study ID Numbers: 475
Study First Received: December 29, 2000
Last Updated: January 20, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Department of Veterans Affairs:
antibiotic treatment
mycoplasma species
Gulf War Veterans' Illnesses (GWI)
mycoplasma positive
Gulf War Syndrome

Additional relevant MeSH terms:
Syndrome
Pleuropneumonia
Mycoplasma Infections
Persian Gulf Syndrome
Disease
Pathologic Processes
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Pleurisy
Pleural Diseases
Respiratory Tract Infections
Mycoplasmatales Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Occupational Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on October 19, 2014