NCT01207739

Persistent Lyme Empiric Antibiotic Study Europe

Persistent Lyme Empiric Antibiotic Study Europe. A Prospective, Randomised Study Comparing Two Prolonged Oral Antibiotic Strategies After Initial Intravenous Ceftriaxone Therapy for Patients With Symptoms of Proven or Possible Persistent Lyme Disease

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 280 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to establish whether prolonged antibiotic treatment of patients diagnosed with proven or presumed PLD (as endorsed by the international ILADS guidelines) leads to better patient outcome than short-term treatment as endorsed by the Dutch CBO guidelines.

Conditions

• Lyme Disease
• Borrelia Infection

Interventions

Type	Name	Description
DRUG	Doxycycline	After open-label i.v. ceftriaxone 2000 mg qd via a peripheral i.v. catheter: oral Doxycycline 100 mg combined with a placebo b.i.d. for 12 weeks
DRUG	Clarithromycin and hydroxychloroquine	After open-label i.v. ceftriaxone 2000 mg qd via a peripheral i.v. catheter: clarithromycin 500 mg combined with hydroxychloroquine 200 mg b.i.d. for 12 weeks
DRUG	Placebo	After open-label i.v. ceftriaxone 2000 mg qd via a peripheral i.v. catheter: 12 weeks' course of double placebo b.i.d.

Timeline

• Start date: 2010-09-01
• Primary completion: 2013-10-01
• Completion: 2014-10-01
• First posted: 2010-09-23
• Last updated: 2016-09-08

Locations

2 sites across 1 country: Netherlands