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Clinical Trials/ISRCTN03563617
ISRCTN03563617CompletedNot Applicable

Phase II, randomised, single-center, open-label study of the efficacy of Ketek® in the treatment of Lyme disease

First Medical Associates (USA)0 sites90 target enrollmentStarted: March 29, 2005Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
90
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •Patients with clinically suspected recurrent LD evaluated in a primary care setting in a Lyme disease endemic area, will be eligible for participation in the study if they meet the selection criteria:
  • •1. Clinically documented disease described by Asch et al. and Logigian et al.
  • •2. History of previous oral and intravenous antibiotics
  • •3. Age 18 years or older to include the elderly (no upper age limits will be established)
  • •4. Both sexes
  • •5. A written informed consent document regarding the experimental nature of the study
  • •6. Ability to comply with the protocol follow-up
  • •7. Women of childbearing potential must be using a medically acceptable method of birth control and have a negative serum Human Chorionic Gonadotropin (HCG) pregnancy test result at the initial screening visit

Exclusion Criteria

  • •Exclusion criteria will be limited to secure inclusion of as many patients as possible, thus avoiding difficulties in generalising the results. Patients will be excluded from the study if:
  • •1. They have not previously been treated for at least 21 days with an antibiotic known to be effective for Lyme disease
  • •2. They are not able to return for follow-up
  • •3. They have a history of allergies to erythromycin, macrolides, or Ketek®
  • •4. They have a history of allergies to both amoxicillin and doxycycline
  • •5. They are pregnant or are a postpartum/lactating female who is nursing

Investigators

Sponsor
First Medical Associates (USA)

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