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Trial record 8 of 25 for:    "Pleural Disease" | "Anti-Bacterial Agents"

Antibiotic Treatment of Gulf War Veterans' Illnesses

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ClinicalTrials.gov Identifier: NCT00007735
Recruitment Status : Completed
First Posted : January 1, 2001
Last Update Posted : January 21, 2009
Sponsor:
Collaborators:
Pfizer
United States Department of Defense
Information provided by:
VA Office of Research and Development

Brief Summary:
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 or disease Intervention/treatment Phase
Persian Gulf Syndrome Mycoplasma Infections Drug: Doxycycline (200mg/day) or Placebo Phase 3

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Detailed Description:

Primary Hypothesis: The primary hypothesis of this study is that antibiotic treatment directed against Mycoplasmaspecies will improve functional status of patients with Gulf War Veterans' Illnesses (GWI) who are tested as mycoplasma positive at baseline. Specifically, the primary objective of the study is to determine whether a 12 month course of doxycycline treatment in deployed Gulf War veterans presenting with symptoms of GWI and testing as mycoplasma positive improves functional status compared to placebo.

Secondary Hypotheses: Secondary objectives of this study are (1) to determine whether doxycycline treatment reduces symptoms of GWI including pain, fatigue and neurocognitive concerns, (2) to determine whether doxycycline treatment converts mycoplasma positive patients to mycoplasma negative status, and (3) to determine if the benefits of 12 months doxycycline treatment persist after termination of treatment.

Intervention: Patients are randomized to either doxycycline (200mg/day) or placebo which they are instructed to take in the morning.

Primary Outcomes: The primary outcome measure is improvement in the Physical Component Scale (PCS) of the SF-36V at follow-up relative to baseline. The primary end point will be the proportion of patients with more than a seven unit increase in the PCS at 12 months. Important secondary outcome measures are a pain scale (McGill Pain Questionnaire), a fatigue scale (Multidimensional Fatigue Inventory), a neurocognitive symptoms scale (Cognitive Failures Questionnaire), and a GWI Symptom Checklist developed specifically for this study.

Study Abstract: 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.

The study is a 30 month, prospective, randomized, double-blind clinical trial. All veterans deployed to the Gulf War between August, 1990 and August, 1991 will be eligible. Patients will be considered to have GWI if they have at least two of three symptoms (fatigue, musculoskeletal pain, neurocognitive dysfunction) that began after August, 1990 and that have lasted more than six months up to the present. Four hundred and fifty of these GWI patients from 28 medical centers who test positive for Mycoplasma fermentans, Mycoplasma gentalium and/or Mycoplasma pneumoniae at baseline and have no exclusion criteria will be entered into the study over a one year recruitment period. These mycoplasma positive species patients will be randomized to one of two treatment groups: (1) patients treated with doxycycline for 12 months and (2) patients given placebo for 12 months. Each patient will receive study medication for 12 months and will be followed for an additional six months after the termination of medications. Patients will be seen monthly during the medication phase and at 18 months. Major evaluations will be completed at baseline and at 3, 6, 9, 12 and 18 months. Patients assigned to doxycycline will receive 200mg/day, which they will be instructed to take in the morning.

MAIN MANUSCRIPT - Submitted to New England Journal of Medicine on February 22, 2002. On May 10, 2002, New Englad Journal of Medicine rejected the manuscript. Manuscript was submitted to LANCET on June 17, 2002 and rejected on July 29, 2002. Manuscript was submitted to JAMA on August 30, 2002 and rejected on September 6, 2002. Manuscript has been resubmitted to JAMA on March 24, 2003.


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Study Type : Interventional  (Clinical Trial)
Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Official Title: CSP #475 - Persian Gulf - Antibiotic Treatment Trial of Gulf War Veterans' Illnesses
Study Start Date : January 1999
Study Completion Date : October 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics
Drug Information available for: Doxycycline





Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00007735


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Locations
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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
US Department of Veterans Affairs
Pfizer
United States Department of Defense

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ClinicalTrials.gov Identifier: NCT00007735     History of Changes
Other Study ID Numbers: 475
First Posted: January 1, 2001    Key Record Dates
Last Update Posted: January 21, 2009
Last Verified: February 2007
Keywords provided by VA Office of Research and Development:
antibiotic treatment
mycoplasma species
Gulf War Veterans' Illnesses (GWI)
mycoplasma positive
Gulf War Syndrome
Additional relevant MeSH terms:
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Pleural Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Mycoplasma Infections
Pleuropneumonia
Persian Gulf Syndrome
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Pleurisy
Respiratory Tract Infections
Mycoplasmatales Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Occupational Diseases
Doxycycline
Anti-Infective Agents
Antitubercular Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents