Antibiotic Treatment of Gulf War Veterans' Illnesses

NCT00007735 | Completed Phase 3

• 1 other identifier: 475
• Study Type: interventional
• Target: 450
• Locations: 2 countries
• Sites: 27

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.

Conditions

Persian Gulf Syndrome; Mycoplasma Infections

Keywords

antibiotic treatment; mycoplasma species; Gulf War Veterans' Illnesses (GWI); mycoplasma positive; Gulf War Syndrome

Interventions

Doxycycline (200mg/day) or Placebo DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• US Department of Veterans Affairs: lead
• Pfizer: collaborator
• United States Department of Defense: collaborator

Study Sites (27)

Vamc - Birmingham, Al

Birmingham, Alabama, 35233, United States

Location

Naval Health Research Center Merchant Illness Divi

San Diego, California, 92152, United States

Location

Uniformed Services University Department of Psychi

Washington D.C., District of Columbia, 20307-5001, United States

Location

Vamc - Augusta, Ga

Augusta, Georgia, 30904-6285, United States

Location

Vamc - Hines,Il

Hines, Illinois, 60141, United States

Location

Vamc - New Orleans, La

New Orleans, Louisiana, 70146, United States

Location

Vamc - Boston, Ma

Boston, Massachusetts, 02130, United States

Location

Vamc - Omaha, NE

Omaha, Nebraska, 68105, United States

Location

Vamc - Manchester,Nh

Manchester, New Hampshire, 03103, United States

Location

Vamc - East Orange, Nj

East Orange, New Jersey, 07018, United States

Location

Vamc - Albuquerque, Nm

Albuquerque, New Mexico, 87108, United States

Location

Vamc - Albany, Ny

Albany, New York, 12208, United States

Location

Vamc - Brooklyn, Ny

Brooklyn, New York, 11209, United States

Location

Vamc - Bronx,Ny

The Bronx, New York, 10468, United States

Location

Vamc - Durham, Nc

Durham, North Carolina, 27705, United States

Location

Vamc - Fargo, Nd

Fargo, North Dakota, 58102-2498, United States

Location

Vamc - Dayton, Oh

Kettering, Ohio, 45429, United States

Location

Vamc - Oklahoma City, Ok

Oklahoma City, Oklahoma, 73104, United States

Location

Vamc - Philadelphia, Pa

Philadelphia, Pennsylvania, 19104, United States

Location

Vamc - Providence, Ri

Providence, Rhode Island, 02908-4799, United States

Location

Vamc - Charleston, Sc

Charleston, South Carolina, 29401-5799, United States

Location

Vamc - Nashville, Tn

Nashville, Tennessee, 37212-2637, United States

Location

Vamc - Houston, Tx

Houston, Texas, 77030-4298, United States

Location

Vamc - White River Junction

White River Junction, Vermont, 05009, United States

Location

Vamc - Richmond, Va

Richmond, Virginia, 23249, United States

Location

Vamc - Milwaukee, Wi

Milwaukee, Wisconsin, 53295, United States

Location

Vamc - San Juan, Pr

San Juan, 00927, Puerto Rico

Location

MeSH Terms

Conditions

Persian Gulf Syndrome; Mycoplasma Infections

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Occupational Diseases; War-Related Injuries; Wounds and Injuries; Mycoplasmatales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Intervention Model: PARALLEL
• Sponsor Type: FED

Study Record Dates

• First Submitted: December 29, 2000
• First Posted: January 1, 2001
• Study Start: January 1, 1999
• Study Completion: October 1, 2001
• Last Updated: October 30, 2023

Record last verified: 2007-02

Locations

PR (1); US (26)