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NCT00001101 · ClinicalTrials.gov registry record · Phase 3

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of the Safety and Efficacy of Ceftriaxone and Doxycycline in the Treatment of Patients With Seropositive Chronic Lyme Disease

A Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 3
Development phase
194
Enrollment target

NCT00001101 is a Phase 3 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 194 participants.

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The verdict

NCT00001101, a Phase 3 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 3
Development phase
194 participants
Enrollment target

Study Summary

Lyme disease is the most common tick-borne disease in the United States. It is caused by the spirochete Borrelia burgdorferi. It may exist in a chronic form and be the result of: 1) active infection by B. burgdorferi; 2) damage caused by the original infectious process; or 3) the presence of co-infection with another organism transmitted by Ixodes ticks. The purpose of this study is to determine the safety and effectiveness, for seropositive patients, of intensive antibiotic treatment in eliminating symptoms of Chronic Lyme Disease (CLD).

Interventions

  • DRUG ceftriaxone
  • DRUG doxycycline

Trial Details

FieldValue
Enrollment Target 194 participants
Est. Completion 2001-03
Phase Phase 3

What the Registry Record Tells You About NCT00001101

The ClinicalTrials.gov registry entry for NCT00001101 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 194 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which ceftriaxone is the first listed.

NCT00001101 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00001101 about?

NCT00001101 is a clinical study titled "A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of the Safety and Efficacy of Ceftriaxone and Doxycycline in the Treatment of Patients With Seropositive Chronic Lyme Disease". Lyme disease is the most common tick-borne disease in the United States. It is caused by the spirochete Borrelia burgdorferi. It may exist in a chronic form and be the result of: 1) active infection by B. burgdorferi; 2) damage caused by the original infectious process; or 3) the presence of co-infe...

What is the current status of trial NCT00001101?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 194 participants. Estimated completion is 2001-03.

What interventions are being tested in trial NCT00001101?

The interventions under investigation include: ceftriaxone (DRUG), doxycycline (DRUG).

Who is sponsoring clinical trial NCT00001101?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.