Antibiotic Treatment of Gulf War Veterans' Illnesses
Information source: Department of Veterans Affairs
Information obtained from ClinicalTrials.gov on March 24, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Persian Gulf Syndrome; Mycoplasma Infections
Intervention: Doxycycline (200mg/day) or Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Department of Veterans Affairs
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.
Clinical Details
Official title: CSP #475 - Persian Gulf - Antibiotic Treatment Trial of Gulf War Veterans' Illnesses
Study design: Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Vamc - San Juan, Pr, San Juan 00927, Puerto Rico
Vamc - Birmingham, Al, Birmingham, Alabama 35233, United States
Naval Health Research Center Merchant Illness Divi, San Diego, California 92152, United States
Uniformed Services University Department of Psychi, Washington, District of Columbia 20307-5001, United States
Vamc - Augusta, Ga, Augusta, Georgia 30904-6285, United States
Vamc - Hines,Il, Hines, Illinois 60141, United States
Vamc - New Orleans, La, New Orleans, Louisiana 70146, United States
Vamc - Boston, Ma, Boston, Massachusetts 02130, United States
Vamc - Omaha, Ne, Omaha, Nebraska 68105, United States
Vamc - Manchester,Nh, Manchester, New Hampshire 03103, United States
Vamc - East Orange, Nj, East Orange, New Jersey 07018, United States
Vamc - Albuquerque, nm, Albuquerque, New Mexico 87108, United States
Vamc - Albany, Ny, Albany, New York 12208, United States
Vamc - Brooklyn, Ny, Brooklyn, New York 11209, United States
Vamc - Bronx,Ny, Bronx, New York 10468, United States
Vamc - Durham, Nc, Durham, North Carolina 27705, United States
Vamc - Fargo, Nd, Fargo, North Dakota 58102-2498, United States
Vamc - Dayton, Oh, Kettering, Ohio 45429, United States
Vamc - Oklahoma City, Ok, Oklahoma City, Oklahoma 73104, United States
Vamc - Philadelphia, Pa, Philadelphia, Pennsylvania 19104, United States
Vamc - Providence, Ri, Providence, Rhode Island 02908-4799, United States
Vamc - Charleston, Sc, Charleston, South Carolina 29401-5799, United States
Vamc - Nashville, Tn, Nashville, Tennessee 37212-2637, United States
Vamc - Houston, Tx, Houston, Texas 77030-4298, United States
Vamc - White River Junction, White River Junction, Vermont 05009, United States
Vamc - Richmond, Va, Richmond, Virginia 23249, United States
Vamc - Milwaukee, Wi, Milwaukee, Wisconsin 53295, United States
Additional Information
Starting date: January 1999
Ending date: October 2001
Last updated: February 2, 2007
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