Phase II, randomised, single-center, open-label study of the efficacy of Ketek® in the treatment of Lyme disease
| ISRCTN | ISRCTN03563617 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN03563617 |
| Protocol serial number | 876N |
| Sponsor | First Medical Associates (USA) |
| Funder | Not provided at time of registration |
- Submission date
- 20/03/2005
- Registration date
- 29/03/2005
- Last edited
- 13/06/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Daniel Cameron
Scientific
Scientific
175 Main Street
Mt. Kisco
New York
10549
United States of America
| Phone | +1 914 666 4665 |
|---|---|
| Cameron@LymeProject.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study objectives | 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 concentrationtime 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Lyme disease (LD) |
| Intervention | Ketek® versus Amoxicillin (comparator) |
| Intervention type | Drug |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Ketek, Axoxicillin |
| Primary outcome measure(s) |
Success using clinical impression |
| Key secondary outcome measure(s) |
1. Short Form health survey (SF-36) |
| Completion date | 30/04/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 90 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2005 |
| Date of final enrolment | 30/04/2007 |
Locations
Countries of recruitment
- United States of America
Study participating centre
175 Main Street
New York
10549
United States of America
10549
United States of America
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
