Single-investigator, randomized, double-blind, placebo-controlled trial of the efficacy and safety of oral antibiotics versus placebo in recurrent seropositive and seronegative Lyme disease

ISRCTN	ISRCTN19325889
DOI	https://doi.org/10.1186/ISRCTN19325889
Secondary identifying numbers	100

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

Dr Daniel Cameron
Scientific

175 Main Street
Mt. Kisco
10549
United States of America

Phone	+1 914 666 4665
Email	Cameron@LymeProject.com

Study design	Single-investigator, randomized, double-blind, placebo-controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study objectives	To evaluate the effectiveness and safety of oral antibiotics in treating recurrent seropositive and seronegative Lyme disease
Ethics approval(s)	Approved by the Western Institutional Review Board on 29/12/2000, reference number: 1391 WIRB
Health condition(s) or problem(s) studied	Recurrent Lyme disease
Intervention	Amoxicillin versus placebo
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Amoxycillin
Primary outcome measure	Clinical efficacy
Secondary outcome measures	1. Short form 36 (SF-36) 2. Review of symptom severity (ROSS)
Overall study start date	01/01/2001
Completion date	01/01/2004

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	108 seropositive and 108 seronegative
Key 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
Key exclusion criteria	1. Signs: erythema migrans or physical sign (arthritis, Bells 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
Date of first enrolment	01/01/2001
Date of final enrolment	01/01/2004

175 Main Street

Mt. Kisco
10549
United States of America

Lyme Disease Practice and Research (USA)
Research organisation

175 Main Street
Mt. Kisco
10549
United States of America

Research organisation

Lyme Disease Association and First Medical Associates

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan