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NCT00000938 · 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 Seronegative Chronic Lyme Disease

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

Completed
Registry status
Phase 3
Development phase
66
Enrollment target

NCT00000938: Completed Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT00000938 is a Phase 3 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 66 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00000938, a Phase 3 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 3
Development phase
66 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) persistent infection by B. burgdorferi; 2) damage caused by the original infectious process; or 3) the presence of coinfection with another organism transmitted by Ixodes ticks. The purpose of this study is to determine the safety and effectiveness, in seronegative patients, of intensive antibiotic treatment in eliminating symptoms of Chronic Lyme Disease (CLD).

Interventions

  • DRUG ceftriaxone
  • DRUG doxycycline

Trial Details

FieldValue
Enrollment Target 66 participants
Est. Completion 2005-11
Phase Phase 3

What the finished NCT00000938 record still lists

NCT00000938 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower).

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

NCT00000938 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00000938 about?

NCT00000938 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 Seronegative 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) persistent infection by B. burgdorferi; 2) damage caused by the original infectious process; or 3) the presence of coi...

What is the current status of trial NCT00000938?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 66 participants. Estimated completion is 2005-11.

What interventions are being tested in trial NCT00000938?

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

Who is sponsoring clinical trial NCT00000938?

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

How this trial's enrollment target compares

Where NCT00000938's enrollment target sits among peer trials

66 1797th of 2000 higher than 204 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00000938, the US trial registry maintained by the National Library of Medicine. NCT00000938 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.