Health TrialsbyHealthPanel

Doxycycline Boosted Therapy in Lyme Borreliosis: DoBo Study.

ConditionLyme Borreliosis, Nervous System
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorRadboud University Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

Known contra-indication for used study medication.

Women who are pregnant or lactating

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hydroxychloroquin

    Drug

    Added to the standard of care for Lyme Disease

  • Placebo

    Drug

    Standard of care in combination with placebo

  • Doxycycline

    Drug

    Standard of care

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Doxycycline in combination with HydroxychloroquineExperimental treatment 2 interventions
Group B: Doxycycline in combination with placeboPlacebo comparator 2 interventions

Trial outcomes

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

Time frame
Week 4

Secondary outcomes

1

Safety of the study medication

ATL (U/L), creat (μmol/L) and adverse events

Time frame
Week 4 and week 12
2

Tolerability of the study medication

Improvement on subscales of SF-36 questionnaire (Pain and physical function). 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.

Time frame
Week 4 and week 12
3

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

Time frame
Week 52

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Radboud University Medical Center

Lead sponsor

Ministerie van Volksgezondheid, Welzijn en Sport

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: