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Trial record 2 of 5 for:
Recruiting, Not yet recruiting, Available Studies | "Glossitis, Benign Migratory"
Antibiotic Treatment of Multiple Erythema Migrans
This study is currently recruiting participants.
Verified May 2017 by Franc Strle, University Medical Centre Ljubljana
Sponsor:
University Medical Centre Ljubljana
Information provided by (Responsible Party):
Franc Strle, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier:
NCT01163994
First received: July 13, 2010
Last updated: May 4, 2017
Last verified: May 2017
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Purpose
The purpose of this study is to compare the efficacy and safety of 15-day ceftriaxone versus 15-day doxycycline treatment in patients with multiple erythema migrans.
| Condition | Intervention |
|---|---|
| Multiple Erythema Migrans | Drug: ceftriaxone Drug: doxycycline Other: erythema migrans patients treated with doxycycline |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: No masking Primary Purpose: Treatment |
| Official Title: | Comparison of Ceftriaxone and Doxycycline for Treatment of Multiple Erythema Migrans |
Resource links provided by NLM:
Drug Information available for:
Doxycycline
Doxycycline monohydrate
Doxycycline hyclate
Ceftriaxone
Ceftriaxone sodium
Doxycycline calcium
U.S. FDA Resources
Further study details as provided by Franc Strle, University Medical Centre Ljubljana:
Primary Outcome Measures:
- Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days. [ Time Frame: enrolling 3 years, 1 year follow-up for individual participant: first assessment at baseline ]
- Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days. [ Time Frame: second assessment at 14 days postenrollment ]
- Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days. [ Time Frame: third assessment at 2 months postenrollment ]
- Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days. [ Time Frame: fourth assessment at 6 months postenrollment ]
- Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days. [ Time Frame: fifth assessment at 12 months postenrollment ]
Secondary Outcome Measures:
- Comparison of subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, or irritability between patients treated with antibiotic for multiple erythema migrans and control subjects without a history of Lyme borreliosis. [ Time Frame: enrolling 3 years, 1 year follow-up for individual participant: first assessment at baseline ]
- Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients with solitary versus multiple erythema migrans after antibiotic treatment. [ Time Frame: enrolling 3 years, 1 year follow-up for individual participant: at baseline and at 14 days, 2, 6, and 12 months thereafter ]
- Comparison of subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, or irritability between patients treated with antibiotic for multiple erythema migrans and control subjects without a history of Lyme borreliosis. [ Time Frame: second assessment at 6 months postenrollment ]
- Comparison of subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, or irritability between patients treated with antibiotic for multiple erythema migrans and control subjects without a history of Lyme borreliosis. [ Time Frame: third assessment at 6 months postenrollment ]
- Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients with solitary versus multiple erythema migrans after antibiotic treatment. [ Time Frame: second assessment at 14 days postenrollment ]
- Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients with solitary versus multiple erythema migrans after antibiotic treatment. [ Time Frame: third assessment at 2 months postenrollment ]
- Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients with solitary versus multiple erythema migrans after antibiotic treatment. [ Time Frame: fourth assessment at 6 months postenrollment ]
- Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients with solitary versus multiple erythema migrans after antibiotic treatment. [ Time Frame: fifth assessment at 12 months postenrollment ]
| Estimated Enrollment: | 500 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | October 2017 |
| Estimated Primary Completion Date: | October 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: MEM-ceftriaxone |
Drug: ceftriaxone
intravenously, 2 g, qd, 15 days
|
| Active Comparator: MEM-doxycycline |
Drug: doxycycline
orally, 100 mg, bid, 15 days
|
| No Intervention: controls | |
| Active Comparator: EM-doxycycline |
Other: erythema migrans patients treated with doxycycline
orally, 100 mg, bid, 15 days
|
Eligibility| Ages Eligible for Study: | 15 Years and older (Child, Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- multiple erythema migrans in patients > 15 years
Exclusion Criteria:
- a history of Lyme borreliosis in the past
- pregnancy or lactation
- immunocompromised status
- serious adverse event to doxycycline or beta lactam antibiotic
- taking antibiotic with antiborrelial activity within 10 days
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01163994
Please refer to this study by its ClinicalTrials.gov identifier: NCT01163994
Contacts
| Contact: Dasa Stupica, MD | +386 1 522 2110 | cerar.dasa@gmail.com | |
| Contact: Franc Strle, MD | +386 1 522 2610 | franc.strle@kclj.si |
Locations
| Slovenia | |
| UMC Ljubljana, Department of Infectious Diseases | Recruiting |
| Ljubljana, Slovenia, 1525 | |
| Contact: Dasa Stupica, MD +386 1 522 2110 cerar.dasa@gmail.com | |
| Contact: Franc Strle, MD +386 1 5222610 franc.strle@kclj.si | |
| Sub-Investigator: Petra Bogovic, MD | |
| Sub-Investigator: Katarina Ogrinc, MD | |
| Sub-Investigator: Eva Ruzic-Sabljic, MD | |
| Sub-Investigator: Tjasa Cerar, Dipl Microbiol | |
Sponsors and Collaborators
University Medical Centre Ljubljana
Investigators
| Study Chair: | Franc Strle, MD | UMC Ljubljana |
| Principal Investigator: | Dasa Stupica, MD | UMC Ljubljana, Department of Infectious Diseases Ljubljana, Slovenia |
More Information
| Responsible Party: | Franc Strle, M.D., PhD, University Medical Centre Ljubljana |
| ClinicalTrials.gov Identifier: | NCT01163994 History of Changes |
| Other Study ID Numbers: |
MEM-0510 |
| Study First Received: | July 13, 2010 |
| Last Updated: | May 4, 2017 |
Keywords provided by Franc Strle, University Medical Centre Ljubljana:
|
erythema migrans Lyme borreliosis ceftriaxone treatment |
doxycycline treatment outcome subjective symptoms |
Additional relevant MeSH terms:
|
Glossitis, Benign Migratory Erythema Erythema Chronicum Migrans Skin Diseases Lyme Disease Borrelia Infections Gram-Negative Bacterial Infections Bacterial Infections Tick-Borne Diseases Skin Diseases, Bacterial Spirochaetales Infections Skin Diseases, Infectious |
Infection Glossitis Tongue Diseases Mouth Diseases Stomatognathic Diseases Doxycycline Ceftriaxone Anti-Bacterial Agents Anti-Infective Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents |
ClinicalTrials.gov processed this record on July 28, 2017