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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 36 months
Awards & highlights

T-4 Trial Summary

This trial is testing whether a 3-month course of tetracycline is better than a 3-month course of placebo at improving acne. Patients will be randomly assigned to one of the two treatments and will not know which they are receiving. The study will last for 6 months.

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.Check my eligibility
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.See study design
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.

T-4 Trial 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.

T-4 Trial Timeline

Screening ~ 7 days
Treatment ~ 6 months
Follow Up ~36 months
This trial's timeline: 7 days for screening, 6 months for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Participant Retention
Tolerability as assessed by number of side effects
Tolerability as assessed by severity of side effects
Secondary outcome measures
Fatigue as assessed by the Fatigue Severity Scale

T-4 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.

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,256 Previous Clinical Trials
14,820,011 Total Patients Enrolled
2 Trials studying Lyme Disease
120 Patients Enrolled for Lyme Disease
John N. Aucott, MDPrincipal InvestigatorJohns Hopkins University

Media Library

Tetracycline (Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT05219929 — Phase 2
Lyme Disease Research Study Groups: Tetracycline First, Placebo First
Lyme Disease Clinical Trial 2023: Tetracycline Highlights & Side Effects. Trial Name: NCT05219929 — Phase 2
Tetracycline (Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05219929 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are investigators presently looking for volunteers for this research project?

"According to the website, this specific trial is not currently looking for patients. Although it was first posted on November 2nd, 2022 and last updated on November 4th, there are 7 other trials that are still open to enrolling participants."

Answered by AI

Are there any dangers in taking Tetracycline First?

"Tetracycline First is currently in Phase 2 of clinical trials, which indicates that while there is evidence backing its safety, more research needs to be conducted to support claims of efficacy."

Answered by AI

Could you list the specific requirements for study participants?

"This study is searching for 60 individuals who have lyme disease and fall between 18-80 years old. The patients must also Meet the criteria operationalized from the Infectious Diseases Society of America (IDSA) case definition for PTLD, including having a Fatigue Severity Scale survey score of at least 4.0 signifying moderate or greater severity of fatigue. Additionally, they should have a definite LD diagnosis with 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,"

Answered by AI

Can people of all ages participate in this clinical trial?

"To be eligible for this study, patients must have celebrated their 18th birthday but not yet reached their 80th."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
New York
How old are they?
18 - 65
What site did they apply to?
Johns Hopkins Lyme Disease Research Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I've suffered from Lyme since 2014. I have had to end my career in Healthcare in 2021.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Tetracycline Treatment Tolerability Trial
2022. "Tetracycline Treatment Tolerability Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05219929.
All > Lyme Disease
~14 spots leftby Oct 2024
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