Clinical Trial: Persistent Lyme Empiric Antibiotic Study Europe

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Persistent Lyme Empiric Antibiotic Study Europe. A Prospective, Randomised Study Comparing Two Prolonged Oral Antibiotic Strategies After Initial Intravenous Ceftriaxone Therapy for Patients With Symp

Brief 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.

Detailed Summary:
Sponsor: Radboud University

Current Primary Outcome: Global score 36-item Short-form General Health Survey (SF 36) [ Time Frame: Week 14 ]

Because different operationalizations of the term 'Global score 36-item Short-form General Health Survey (SF 36)' exist, the primary outcome measure is specified here as the 'physical component summary score' (PCS) of the RAND-36 Health Status Inventory (RAND SF-36, Hays 1998), which is similar to the Medical Outcomes Study (MOS) 36-item Short-Form General Health Survey (SF-36). The PCS is also known as the physical health composite score (PHC). This specification has been communicated to the local Ethics Committee on March 1, 2011, and was approved on April 6, 2011.


Original Primary Outcome: Global score 36-item Short-form General Health Survey (SF 36) [ Time Frame: Week 14 ]

Current Secondary Outcome:

  • Subscales 36-item Short-form General Health Survey (SF 36) [ Time Frame: weeks 0, 14, 26, 40 and 52 ]
    After the last comprehensive outcome assessment at week 40, patients are surveyed by post-study questionnaires at week 52 (protocol version 3.8; dated July 17, 2009; final Ethics Committee approval April 29, 2010).
  • Actometer recording during 14 days (objective physical activity) [ Time Frame: weeks 0, 14 and 40 ]
  • Measurements of neuropsychological impairment [ Time Frame: weeks 0, 14, 26 and 40 ]
  • Economic evaluation: Questionaire EQ-5D, health consumption and productivity of labour [ Time Frame: weeks 0, 14, 26, 40 and 52 ]
    After the last comprehensive outcome assessment at week 40, patients are surveyed by post-study questionnaires at week 52 (protocol version 3.8; dated July 17, 2009; final Ethics Committee approval April 29, 2010).
  • Fatigue subscale of Checklist Individual Strength (CIS) [ Time Frame: weeks 0, 14, 26, 40 and 52 ]
    After the last comprehensive outcome assessment at week 40, patients are surveyed by post-study questionnaires at week 52 (protocol version 3.8; dated July 17, 2009; final Ethics Committee approval April 29, 2010).


Original Secondary Outcome:

  • Subscales 36-item Short-form General Health Survey (SF 36) [ Time Frame: weeks 0, 14, 26 and 40 ]
  • Actometer recording during 14 days (objective physical activity) [ Time Frame: weeks 0, 14 and 40 ]
  • Measurements of neuropsychological impairment [ Time Frame: weeks 0, 14, 26 and 40 ]
  • Economic evaluation: Questionaire EQ-5D, health consumption and productivity of labour [ Time Frame: weeks 0, 14, 26 and 40 ]
  • Fatigue subscale of Checklist Individual Strength (CIS) [ Time Frame: weeks 0, 14, 26, and 40 ]


Information By: Radboud University

Dates:
Date Received: September 22, 2010
Date Started: September 2010
Date Completion:
Last Updated: September 6, 2016
Last Verified: September 2016