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Tetracycline Treatment Tolerability Trial (T-4)

25. september 2026 oppdatert av: Johns Hopkins University

T4 - Tolerabilitetsforsøk med tetracyklinbehandling En pilotstudie som undersøker gjennomførbarheten og toleransen til tetracyklinterapi ved etterbehandling av borreliose (PTLD)

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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

There is precedent for the use of tetracycline class antibiotics as an anti-inflammatory agent in chronic illnesses including dermatologic and rheumatologic illnesses. The 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis (RA) includes long-term therapy with tetracycline in its treatment recommendations. This class of antibiotics has known anti-inflammatory effect in addition to its antimicrobial properties. Tetracyclines, in particular minocycline, have been associated with a significant improvement in disease activity in RA with no increased risk of adverse effects.

To date, no clinical trials have examined the benefit of extended duration; i.e. >4 weeks tetracycline therapy in PTLD. Concerns over side effects and the development of antibiotic-resistance and superinfections such as Clostridioides difficile have limited the use of long-term antibiotics, including tetracycline. There is a large body of literature on tetracycline and other drugs in this class regarding the drugs' anti-inflammatory properties and potential benefit in several non-infectious diseases such cerebrovascular disease, rheumatoid arthritis, and rosacea.

The investigators believe that this deserves further study. Initially, the investigators propose this pilot study to examine the feasibility and tolerability of tetracycline treatment in PTLD Secondarily, the investigators propose to assess preliminary data on the efficacy of 3 months duration tetracycline treatment in reducing PTLD symptoms at (1) the end of the three-month treatment period, and (2) rate of change during the 1st 3 months of treatment.

Lastly, as an exploration, the investigators will explore in the follow-up period the return of symptoms after the completion of the 3 month tetracycline and the effect of 3 months of tetracycline in the placebo arm.

The investigators hypothesize that a tetracycline study over a 4 year interval will be feasible to conduct and tolerable to patients. Secondarily, the investigators hypothesize that 3 months of tetracycline treatment will be associated with greater improvements in fatigue, symptom burden and functional impact than placebo. This research is important because the long-term sequelae of LD are debilitating to patients and costly to society.

Studietype

Intervensjonell

Registrering (Faktiske)

60

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Maryland
      • Lutherville, Maryland, Forente stater, 21093
        • Johns Hopkins Lyme Disease Research Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • ≥ 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.

Exclusion Criteria:

  • 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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Tetracycline First

Tetracycline for first 3 months, placebo for second 3 months.
Legemiddel: Tetracycline 500 Mg

500 mg three times daily

Annen: Placebo

Placebo for Tetracycline given same way as Tetracycline.
Placebo komparator: Placebo First

Placebo for first 3 months, tetracycline for second 3 months.
Legemiddel: Tetracycline 500 Mg

500 mg three times daily

Annen: Placebo

Placebo for Tetracycline given same way as Tetracycline.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Participant Retention
Tidsramme: 36 months

Number of participants retained.
36 months
Tolerability as assessed by number of side effects
Tidsramme: 36 months

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
Tidsramme: 36 months

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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Fatigue as assessed by the Fatigue Severity Scale
Tidsramme: 36 months

A change of 0.7 in the Fatigue Severity Scale will be considered clinically significant
36 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Johns Hopkins University

Samarbeidspartnere

Steve and Alexandra Cohen Foundation

Etterforskere

  • Hovedetterforsker: John N. Aucott, MD, Johns Hopkins University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

2. november 2022

Primær fullføring (Faktiske)

9. juni 2026

Studiet fullført (Faktiske)

9. juni 2026

Datoer for studieregistrering

Først innsendt

21. januar 2022

Først innsendt som oppfylte QC-kriteriene

21. januar 2022

Først lagt ut (Faktiske)

2. februar 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • IRB00288079

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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