Condition category
Infections and Infestations
Date applied
02/03/2006
Date assigned
22/03/2006
Last edited
16/08/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.lymeproject.com

Contact information

Type

Scientific

Primary contact

Dr Daniel Cameron

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

100

Study information

Scientific title

Acronym

Study hypothesis

To evaluate the effectiveness and safety of oral antibiotics in treating recurrent seropositive and seronegative Lyme disease

Ethics approval

Approved by the Western Institutional Review Board on 29/12/2000, reference number: 1391 WIRB

Study design

Single-investigator, randomized, double-blind, placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Recurrent Lyme disease

Intervention

Amoxicillin versus placebo

Intervention type

Drug

Phase

Not Specified

Drug names

Amoxycillin

Primary outcome measures

Clinical efficacy

Secondary outcome measures

1. Short form 36 (SF-36)
2. Review of symptom severity (ROSS)

Overall trial start date

01/01/2001

Overall trial end date

01/01/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. 18 years or older to include the elderly
2. Both sexes
3. Outpatients
4. A signed consent must be obtained
5. Diagnostic criteria: Lyme disease symptomology as described by Logigian et al

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

108 seropositive and 108 seronegative

Participant exclusion criteria

1. Signs: erythema migrans or physical sign (arthritis, Bell’s palsy, heart block, or meningitis) require treatment and therefore cannot be placed into a placebo arm
2. Inadequate initial treatment: patients not previously treated with at least 21 consecutive days with an antibiotic known to be effective for Lyme disease
3. Patients without any clinical evidence of Lyme disease
4. Patients anticipated to not able to return for follow-up examination
5. Patients with a type 1 hypersensitivity to penicillins
6. Pregnancy and postpartum or lactating female who is nursing
7. Other antibiotics: anticipated requirement of systemic antibiotics other than the study medication
8. Initial treatment failure: patients cannot be enrolled in the re-treatment subgroup if failing the first treatment
9. Medication failure: patients cannot be enrolled if they have a history of failing study medication

Recruitment start date

01/01/2001

Recruitment end date

01/01/2004

Locations

Countries of recruitment

United States of America

Trial participating centre

175 Main Street
Mt. Kisco
10549
United States of America

Sponsor information

Organisation

Lyme Disease Practice and Research (USA)

Sponsor details

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

Sponsor type

Research organisation

Website

http://www.lymeproject.com

Funders

Funder type

Research organisation

Funder name

Lyme Disease Association and First Medical Associates

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