Doxycycline Boosted Therapy in Lyme Borreliosis: DoBo Study.

NCT07230028 | Not Yet Recruiting Phase 4

• 2 other identifiers: DoBo2025-523078-18-00
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to learn if hydroxychloroquine works to treat long-term complaints attributed to Lyme borreliosis in adults. The main questions it aims to answer are: Does addition of hydroxychloroquine reduce physical complaints? Researchers will compare hydroxychloroquine to a placebo (a look-alike substance that contains no drug) to see if hydroxychloroquine works to treat Lyme borreliosis. Participants will: Take hydroxychloroquine or a placebo two times a day during 28 days. Visit the clinic 4 times in one year for checkups and tests.

Conditions

Lyme Borreliosis, Nervous System

Keywords

Hydroxychloroquine

Outcome Measures

Primary Outcomes (1)

• Health-related quality of life.

  Global physical health composite score of the 36-item Short-form General Health Survey (SF-36). Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100. Higher scores indicating better health and lower scores indicating worse health or disability

  Week 4

Secondary Outcomes (3)

• Safety of the study medication

  Week 4 and week 12

• Tolerability of the study medication

  Week 4 and week 12

• Health-related quality of life

  Week 52

Study Arms (2)

Doxycycline in combination with Hydroxychloroquine

EXPERIMENTAL

Doxycycline (standard of care) in combination with Hydroxychloroquine 2 x 200 mg (two times a day one tablet).

Drug: Hydroxychloroquin; Drug: Doxycycline

Doxycycline in combination with placebo

PLACEBO COMPARATOR

Doxycycline (standard of care) in combination with Placebo (two times a day one tablet).

Drug: Placebo; Drug: Doxycycline

Interventions

Hydroxychloroquin DRUG

Added to the standard of care for Lyme Disease

Also known as: Plaquenil

Doxycycline in combination with Hydroxychloroquine

Placebo DRUG

Standard of care in combination with placebo

Doxycycline in combination with placebo

Doxycycline DRUG

Standard of care

Doxycycline in combination with Hydroxychloroquine; Doxycycline in combination with placebo

Eligibility Criteria

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

You may qualify if:

• Patients who are 18 years of age or older
• Patients with probable or possible signs and symptoms attributed to Lyme borreliosis
• Patients with probable or possible post Lyme treatment Lyme borreliosis syndrome (PTLBS)
• Males or non-pregnant females (who must agree to use barrier methods of contraception during the study therapy period, women of childbearing age must have a negative urine pregnancy or serum test at baseline).

You may not qualify if:

• Known contra-indication for used study medication.
• Women who are pregnant or lactating

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Ministerie van Volksgezondheid, Welzijn en Sport: collaborator

MeSH Terms

Conditions

Lyme Neuroborreliosis

Interventions

Hydroxychloroquine; Doxycycline

Condition Hierarchy (Ancestors)

Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Lyme Disease; Gram-Negative Bacterial Infections; Borrelia Infections; Spirochaetales Infections; Central Nervous System Infections; Tick-Borne Diseases; Vector Borne Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Hadewych Ter Hofstede, Dr.

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hadewych ter Hofstede, Dr.

CONTACT

+3124361819; hadewych.terhofstede@radboudumc.nl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: November 17, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share