Condition category
Infections and Infestations
Date applied
20/03/2005
Date assigned
29/03/2005
Last edited
13/06/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Daniel Cameron

ORCID ID

Contact details

175 Main Street
Mt. Kisco
New York
10549
United States of America
+1 914 666 4665
Cameron@LymeProject.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

876N

Study information

Scientific title

Acronym

Study hypothesis

This study will examine the hypothesis that Ketek® is as effective as amoxicillin in treating Lyme Disease (LD). The validity of our in vitro infection model will be strengthened by measuring telithromycin maximal plasma concentration and the area under the concentration–time curve (AUC). Patients completing the duration study will be allowed to enter long-term open-label follow-up studies. These proof of concept findings would lead to at least one large multicenter confirmatory, double-blind, randomised, comparator, parallel-group Phase III study.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Lyme disease (LD)

Intervention

Ketek® versus Amoxicillin (comparator)

Intervention type

Drug

Phase

Phase II

Drug names

Ketek, Axoxicillin

Primary outcome measures

Success using clinical impression

Secondary outcome measures

1. Short Form health survey (SF-36)
2. Review Of Symptoms Scale (ROSS)

Overall trial start date

01/09/2005

Overall trial end date

30/04/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

90

Participant 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

Recruitment start date

01/09/2005

Recruitment end date

30/04/2007

Locations

Countries of recruitment

United States of America

Trial participating centre

175 Main Street
New York
10549
United States of America

Sponsor information

Organisation

First Medical Associates (USA)

Sponsor details

175 Main Street
Mt. Kisco
New York
10549
United States of America
+1 914 666 4665
Cameron@LymeProject.com

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Not provided at time of registration

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes