Trial · NCT06785402
Ceftriaxone for Post-Treatment Lyme Disease
NCT06785402, Phase 1, Phase 2, Withdrawn, Hackensack Meridian Health
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ceftriaxone for Post-Treatment Lyme Disease. Trials, record NCT06785402. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06785402
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ceftriaxone for Post-Treatment Lyme Disease
- NCT number
- NCT06785402
- Status
- Withdrawn
- Phases
- Phase 1, Phase 2
- Enrollment
- 0 participants, actual
- Lead sponsor
- Hackensack Meridian Health
- Conditions
- Post-Treatment Lyme Disease Syndrome
- Interventions
- Ceftriaxone treatment, Placebo
- First posted
- 2025-01-21
- Last updated
- 2026-05-18
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety of pulse-dosed ceftriaxone | 12 months post treatment initiation | To assess the safety of pulse-dosed ceftriaxone in PTLDS when compared to placebo as well as historical data based on the number of reported adverse and serious adverse events. |
| Primary | Tolerability of pulse-dosed ceftriaxone | 12 months post treatment initiation | To assess the tolerability of pulse-dosed ceftriaxone in PTLDS when compared to placebo as well as historical data based on the number of reported adverse and serious adverse events. |
| Primary | Study Feasibility | 6 month enrollment period | To assess the recruit the patients within the pre-determined period of time (6 months). |
| Secondary | Clinical Improvement - Physical and mental summary indices | 12 months post treatment initiation | To assess clinical improvement after treatment using additional clinical outcome measures. Primary functional change with the physical and mental summary indices of the SF-36 as either responder or non-responder (a change of 6.5 points on the SF-physical health summary scale, and 7.9 points on the mental health summary scale respectively). Eight scales are used and when combined measure the physical and mental health of participants. Each scale is scored to have same average (50) and the same standard deviation (10 points). with a score below 50 representing below average health. |
| Secondary | Clinical Improvement - General Symptom Questionnaire (GSQ-30) | 12 months post treatment initiation | To assess clinical improvement after treatment using additional clinical outcome measures. General Symptom Questionnaire (GSQ-30).GSQ-30 us used to assess symptom burden and specifically pain/fatigue, neuropsychiatric, neurologic, and viral-like symptom burden impacting function. Each symptom is measured on scale of 0 (not at all) to 4 (very much) for an overall score of 0-120 with higher scores representing higher burden. |
| Secondary | Clinical Improvement - PROMIS-29 | 12 months post treatment initiation | To assess clinical improvement after treatment using additional clinical outcome measures using PROMIS-29 which has multiple sections and scoring varies by section. The min/max are as follows: Physical Function (PF) 4-20, Anxiety 4-20, Depression 4-20, Fatigue 4-20, Sleep Disturbance- 4-20, Ability to Participate in Social Roles and Activities (APSRA) 4-20, Pain Interference 4-20, Pain Intensity 0-10. For PF and APSRA, improvement would be tracked by an increase in score. For Anxiety, Depression, Fatigue, Sleep Disturbance, Pain interference, and Pain Intensity improvement would be tracked by a decrease in score. A higher score in PF and APSRA suggest better health. A higher score in Anxiety, Depression, Fatigue, Sleep Disturbance, Pain interference and Pain Intensity suggests lower health. A score change of 5 points or more is considered clinically meaningful. |
| Secondary | Clinical Improvement - Quantitative Lyme VlsE1/pepC10 Ab | 12 months post treatment initiation | To assess clinical improvement after treatment using additional clinical outcome measures changes in quantitative Lyme VlsE1/pepC10 Ab. Higher titers represent higher antibodies. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06785402
GET https://conductscience.org/api/trials/v1/NCT06785402/registered