Tetracycline Treatment Tolerability Trial

NCT05219929 | Enrolling By Invitation Phase 2 FDA Drug

• 1 other identifier: IRB00288079
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized, double-blind, placebo-controlled study (with a one-week washout period) where subjects receive either 3 months of tetracycline or 3 months of placebo. After the 3 month primary endpoint, in the follow-up period, patients will be assigned to the alternate treatment for 3 months with blind maintained.

Conditions

Post-Treatment Lyme Disease

Outcome Measures

Primary Outcomes (3)

• Participant Retention

  Number of participants retained.

  36 months

• Tolerability as assessed by number of side effects

  Tolerability as assessed by number of side effects, as measured by Systematic Assessment for Treatment Emergent Events (SAFTEE).

  36 months

• Tolerability as assessed by severity of side effects

  Tolerability as assessed by severity of side effects, as measured by SAFTEE.

  36 months

Secondary Outcomes (1)

• Fatigue as assessed by the Fatigue Severity Scale

  36 months

Study Arms (2)

Tetracycline First

ACTIVE COMPARATOR

Tetracycline for first 3 months, placebo for second 3 months.

Drug: Tetracycline 500 Mg; Other: Placebo

Placebo First

PLACEBO COMPARATOR

Placebo for first 3 months, tetracycline for second 3 months.

Drug: Tetracycline 500 Mg; Other: Placebo

Interventions

Placebo OTHER

Placebo for Tetracycline given same way as Tetracycline.

Placebo First; Tetracycline First

Tetracycline 500 Mg DRUG

500 mg three times daily

Placebo First; Tetracycline First

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 to 80 years of age
• Meet criteria operationalized from the Infectious Diseases Society of America (IDSA) case definition for PTLD (ref) previously treated with at least one recommended course of antibiotic therapy.
• Have persistent symptoms in at least the last month. "Currently have at least one symptom attributed to Lyme disease that a) you've experienced in the past month and b) limits your daily functioning at least half the time when its present"
• Fatigue Severity Scale survey score of at least 4.0 signifying moderate or greater severity of fatigue.
• Medical Records documented history of definite or probable Lyme disease with onset starts in the last 5 years, with symptoms developing within 1 year of Lyme onset.
• Definite LD. Medical record documented history of erythema migrans or medical record documented history of a Lyme disease compatible neurologic, cardiac or musculoskeletal manifestation of Lyme disease with a confirmatory 2-tier serology, modified 2-tier serologic test, or immunoglobulin G (IgG) western blot and a lack of alternative diagnosis Probable LD. Medical record documented history of Lyme disease with atypical or nonspecific manifestations with a confirmatory 2-tier serology, modified 2-tier serologic test, or IgG western blot and a lack of alternative diagnosis.

You may not qualify if:

• Medications:
• No antibiotics in the prior 2 months No change in medications during the prior 4 months that might have an impact on primary and secondary outcome measures. See list. No immunosuppressive medications No medications that interact with tetracycline: atovaquone, retinoid medications taken by mouth (such as acitretin, isotretinoin), strontium, digoxin, kaolin pectin, warfarin Use of prescription or over the counter (OTC) medications containing calcium (i.e. Tums)
• History of the following conditions predating the diagnosis of Lyme disease: Myalgic encephalomyelitis/chronic fatigue syndrome Fibromyalgia Autoimmune disease
• Major psychiatric conditions Bipolar disorder, delusional disorder, schizophrenia Major depression Suicidal ideation with intent during the prior 6 months
• History of the following conditions in the last 4 months Alcohol or substance abuse Cancer (other than skin) Untreated HIV/AIDS Untreated moderate to severe sleep apnea Hepatitis A, B or C Pregnancy or intent to become pregnant Breastfeeding
• BMI greater than 40
• Other conditions at the discretion of the clinician

Sponsors & Collaborators

• Johns Hopkins University: lead
• Steve and Alexandra Cohen Foundation: collaborator

Study Sites (1)

Johns Hopkins Lyme Disease Research Center

Lutherville, Maryland, 21093, United States

Location

MeSH Terms

Conditions

Post-Lyme Disease Syndrome

Interventions

Tetracycline

Condition Hierarchy (Ancestors)

Lyme Disease; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Borrelia Infections; Spirochaetales Infections; Tick-Borne Diseases; Vector Borne Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• John N. Aucott, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2022
• First Posted: February 2, 2022
• Study Start: November 2, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)