What side effects are associated with this type of intervention?

The most common treatments for Lyme Disease, particularly those involving tetracyclines like doxycycline and minocycline, can cause several side effects. These include gastrointestinal distress, photosensitivity (increased sensitivity to sunlight), and, in rare cases, idiopathic intracranial hypertension (increased pressure in the brain). Tetracyclines can also interfere with the effectiveness of oral contraceptives and are contraindicated in pregnant individuals and children under eight years old due to the risk of permanent tooth discoloration and inhibition of bone growth.

What prior FDA approvals exist?

The FDA has approved several antibiotics for the treatment of Lyme Disease, primarily focusing on those that inhibit bacterial protein synthesis. Doxycycline, a tetracycline antibiotic, is commonly used and recommended for early Lyme disease and as prophylaxis following a tick bite. Other antibiotics such as amoxicillin and cefuroxime axetil are also approved for Lyme disease treatment. For more severe cases, intravenous ceftriaxone has been used, although its use is limited due to potential adverse effects. These treatments aim to eliminate the Borrelia burgdorferi bacteria responsible for Lyme disease.

What other types of research exist?

Promising alternatives to tetracycline for Lyme disease treatment in 2024 include doxycycline, which has a better safety profile, and the combination of roxithromycin and co-trimoxazole, which has shown efficacy in treating late Lyme borreliosis.

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Antibiotic

Tetracycline for Acne (T-4 Trial)

Phase 2

Waitlist Available

Led By John N. Aucott, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥ 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.

Timeline

Screening 7 days

Treatment 6 months

Follow Up 0 months

Summary

This trial tests an antibiotic that reduces inflammation in patients who still have symptoms after standard Lyme disease treatment. The goal is to see if it can improve symptoms like fatigue and pain. The antibiotic has been shown to reduce both bacterial load and inflammation.

Who is the study for?

Adults aged 18-80 with a documented history of Lyme disease onset within the last 5 years and symptoms starting within a year. Participants must have persistent symptoms that affect daily life, have been treated with antibiotics for Lyme disease, and score at least 4.0 on the Fatigue Severity Scale.

What is being tested?

The trial is testing Tetracycline's effectiveness in treating Lyme Disease against a placebo over two periods of three months each. Patients are randomly assigned to start with either the drug or placebo, then switch after three months without knowing which one they're taking.

What are the potential side effects?

Tetracycline may cause side effects like stomach upset, diarrhea, nausea, vomiting, sun sensitivity leading to sunburns more easily than usual, changes in skin color (usually temporary), and rarely serious liver problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 80 years old.

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I have been treated for PTLD with antibiotics as recommended.

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You have a moderate or severe level of fatigue, as indicated by a score of at least 4.0 on the Fatigue Severity Scale survey.

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I have a medical record of Lyme disease starting within the last 5 years and symptoms began within a year of Lyme onset.

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I have a confirmed diagnosis of Lyme disease with specific or nonspecific symptoms.

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I am between 18 and 80 years old.

Timeline

Screening ~ 7 days0 visits

Treatment ~ 6 months3 visits

Follow Up ~ 0 months0 visits

Screening ~ 7 days

Treatment ~ 6 months

Follow Up ~0 months

This trial's timeline: 7 days for screening, 6 months for treatment, and 0 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Participant Retention

Tolerability as assessed by number of side effects

Tolerability as assessed by severity of side effects

Secondary study objectives

Fatigue as assessed by the Fatigue Severity Scale

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Tetracycline FirstActive Control2 Interventions

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

Group II: Placebo FirstPlacebo Group2 Interventions

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

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Tetracyclines, such as doxycycline and tetracycline, are common treatments for Lyme Disease that work by inhibiting bacterial protein synthesis, thereby preventing the bacteria from growing and reproducing. This mechanism is crucial for Lyme Disease patients as it reduces the bacterial load, alleviates symptoms, and prevents disease progression. Understanding this helps in appreciating the effectiveness of these antibiotics in managing Lyme Disease.

[Borrelia infections of the skin--progress of knowledge since the discovery of Lyme disease].Risk of culture-confirmed borrelial persistence in patients treated for erythema migrans and possible mechanisms of resistance.How do tetracyclines work?