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Antibiotic Treatment of Gulf War Veterans' Illnesses

This study has been completed.
Sponsor:
Collaborators:
Pfizer
Department of Defense
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
History of Changes
  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:

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment: 450
Study Start Date: January 1999
Estimated Study Completion Date: October 2001
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  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00007735

  Show 27 Study Locations
Sponsors and Collaborators
Department of Veterans Affairs
Pfizer
Department of Defense
  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:
Pleuropneumonia
Mycoplasma Infections
Persian Gulf Syndrome
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
Doxycycline
Doxycycline hyclate
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on June 17, 2013