Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01368341
Other study ID # EUDRACT 2010-023747
Secondary ID
Status Completed
Phase Phase 4
First received June 6, 2011
Last updated December 11, 2014
Start date June 2011
Est. completion date December 2014

Study information

Verified date December 2014
Source University of Oslo
Contact n/a
Is FDA regulated No
Health authority Norway: Norwegian Medicines Agency
Study type Interventional

Clinical Trial Summary

Tick borne diseases are increasing in Norway. Lyme borreliosis is the most common infection. Erythema migrans is mainly diagnosed and treated in general practice. There is disagreement about what antibiotic treatment that should be given. An RCT with the three most common antibiotics used, will support data for revision of national guidelines.


Description:

Comparison of phenoxymethylpenicillin, doxycycline and amoxicillin for Erythema migrans in Norwegian general practice. Every patient receives 14 days of antibiotic treatment. There are blood samples for measurement of Borrelia antibody level at day 1, 14 and 90 and questionnaires on subjective health complaints (SHC) at day 1, 90 and 360. Side symptoms and side effects are registered. For volunteers there is an additional PCR-analysis on punch biopsy from the EM for subgrouping of the Borrelia bacteria. TBE-antibodies are measured on day 14. Antibody levels and SHC-scores are compared to healthy blood donors.


Recruitment information / eligibility

Status Completed
Enrollment 225
Est. completion date December 2014
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Clinical diagnosis of Erythema migrans

- Over the age of 18

- Signing an concent form after information in writing

Exclusion Criteria:

- Allergic to any of the three drugs in the study

- Under the age of 18

- Pregnancy

- Dementia or known drug abuse

- Antibiotic treatment last 14 days

- Concommitant Chemotherapy or immunomodulating therapy

- Concommitant use of medicine with potential interaction (defined in protocol)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
Doxycycline
1 tablet, 100 mg, b.i.d. 14 days
Phenoxymethylpenicillin
Tablet 650 mg, 2 tablets, t.i.d., 14 days
Amoxicillin
Capsula, 500 mg, t.i.d., 14 days

Locations

Country Name City State
Norway Antibiotic Centre for Primary Care, University of Oslo Oslo

Sponsors (4)

Lead Sponsor Collaborator
Morten Lindbaek Norwegian Institute of Public Health, Norwegian University of Life Sciences, Sorlandet Hospital HF

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Duration of Erythema migrans (EM) On day 1 duration until first the consulation is registered. Day 1-14 the EM is registered in a patient diary. On day 14 the doctor is asked whether the EM has disseapeared. If not the patient is followed by phone from the researchers. On day 90 they are additionally asked for how long it lasted. 1-90 days No
Secondary Subjective Health Complaints (SHC) By questionnaire on day 1, day 90 and day 360 the patients are asked about their SHC which is a standardized set of parametres. The 3 treatment groups are compaired to each other and to 1200 healthy blood donors receiving the same questionnaire. There are 29 standardized and 3 Lyme disease related subjects to be measured. 1 year No
Secondary Borrelia antibodies Normally antibody production is not measured for EM as it is a clinical diagnosis, and less than 50 percent of EM-patients are expected to develop antibodies in the first period. However antibodies are here measured on day 1, day 14 and day 90 to see whether there are differences between the groups. Also the results will be compared to the blood donors. 1-90 days No
Secondary Side symptoms The EM in it self is often asymptomatic, and fever, headache and nerval palsy can be a sign of disseminated disease or co-infection. On the quiestionnaire to the pasient and doctor on day 1, in the patient diary day 1-14 and on the questionnaire to the doctor on day 14 these side symptoms are registered.
In a potential case, where it turns out that the patient suffers from disseminated disease this will be regostered as treatment failure in the study and the patient treated and/or referred as normal.
1-14 days Yes
Secondary Side effects The antibiotic tretments are expected to be non-inferior to each other. Potensial side effects as nausea, diarrhea etc. are registered in the patients diary day 1-14 and in the doctors quiestionnaire on day 14. 1-14 days No
Secondary Subgrouping and TBE For volunteers there is an additional PCR-analysis on punch biopsy from the EM for subgroupring of the Borrelia bacteria. TBE-antibodies are measured on day 14. 1-14 days No
See also
  Status Clinical Trial Phase
Completed NCT01207739 - Persistent Lyme Empiric Antibiotic Study Europe Phase 4
Terminated NCT04577053 - PEMF Therapy to Treat Lingering Symptoms of Lyme Disease After Treatment With Antibiotics N/A
Completed NCT04867473 - Feasibility of Teleyoga for Treatment of Lyme Disease N/A
Recruiting NCT04038346 - Symptomatic Management of Lyme Arthritis Phase 3
Completed NCT01143558 - Searching for Persistence of Infection in Lyme Disease Early Phase 1
Withdrawn NCT04318925 - Evaluation and Follow-up of People With Tick-borne Diseases
Terminated NCT03581279 - Detection of Borrelia Bacteria in Early Stage Lyme Borreliosis Using the T2Lyme Panel N/A
Enrolling by invitation NCT05041595 - Lyme Disease Diagnostic Assay - Collection of Whole Blood
Recruiting NCT03981874 - Peripheral Facial Paralysis Sequelae in Lyme Disease Among Children N/A
Recruiting NCT03963635 - Novel Diagnostics for Early Lyme Disease
Terminated NCT03084614 - CD8 Reactivity to Microorganisms in Blood and Breast Milk
Recruiting NCT04835792 - Biomarker Study of Previously Treated Lyme Disease Volunteers in Comparison to Healthy Volunteers
Recruiting NCT06397794 - Navigating Pregnancy and Parenthood With Lyme Disease
Recruiting NCT04148222 - A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Lyme Disease
Terminated NCT03201042 - Lyme Test Indication Combinations (LyTIC) Study
Terminated NCT00958139 - Passive Prophylaxis of Lyme Disease Using Permethrin Treated Clothes Phase 3
Recruiting NCT00001539 - A Comprehensive Clinical, Microbiological and Immunological Assessment of Patients With Suspected Post Treatment Lyme Disease Syndrome and Selected Control Populations
Recruiting NCT03501407 - Understanding Tick-borne Diseases
Completed NCT04422314 - ImmuneSense Lyme Study
Recruiting NCT04719962 - Direct Diagnosis of Disseminated Lyme Borreliosis. N/A