Persistent Lyme Empiric Antibiotic Study Europe (PLEASE)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01207739 |
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Recruitment Status :
Completed
First Posted : September 23, 2010
Last Update Posted : September 8, 2016
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Sponsor:
Radboud University
Collaborators:
Sint Maartenskliniek
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Radboud University
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lyme Disease Borrelia Infection | Drug: Doxycycline Drug: Clarithromycin and hydroxychloroquine Drug: Placebo | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 280 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 Symptoms of Proven or Possible Persistent Lyme Disease |
| Study Start Date : | September 2010 |
| Actual Primary Completion Date : | October 2013 |
| Actual Study Completion Date : | October 2014 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Lyme disease
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: Doxycycline |
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
Other Names:
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| Active Comparator: Clarithromycin and hydroxychloroquine |
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
Other Names:
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| Placebo Comparator: Placebo |
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. |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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).
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Males or non-pregnant, non-lactating females who are 18 years or older.
- Women of child-bearing potential must agree to use contraception methods other than oral contraceptives during the study therapy period, since failure of oral contraceptives due to long-term antibiotic use has been described and doxycycline might be teratogenic.
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Patients with presumed or proven PLD. In this study, clinical suspicion of PLD is defined as complaints of musculoskeletal pain, arthritis or arthralgia, neuralgia or sensory disturbances (such as paresthesias or dysesthesias), neuropsychological or cognitive disorders, and persistent fatigue, that are:
- temporally related to an episode of erythema migrans or otherwise proven symptomatic Lyme disease (defined as within 4 months after erythema migrans as assessed by a physician, or positive biopsy, PCR, culture, intrathecal B. burgdorferi antibodies), OR
- accompanied by a positive B. burgdorferi IgG or IgM immunoblot (as defined by strict criteria in line with the European Union Concerted Action on Lyme Borreliosis (EUCALB)), regardless of prior ELISA IgG/IgM screening results.
- Subjects must sign a written informed consent form.
Exclusion Criteria:
- Subjects with a known history of allergy or intolerance to tetracyclines, macrolides, hydroxychloroquine or ceftriaxone.
- Subjects who have had more than 5 days of antimicrobial therapy with activity against B. burgdorferi within the previous 4 weeks.
- Subjects with a presumed diagnosis of neuroborreliosis (CSF pleocytosis or intrathecal antibody production) for which intravenous antimicrobial therapy is required.
- Subjects with a known diagnosis of HIV-seropositivity or other immune disorders. (No HIV serologic testing is required for the study).
- Subjects with positive syphilis serology or signs of other spirochetal diseases.
- Subjects with moderate or severe liver disease defined as alkaline phosphatase, ALAT, or ASAT greater than 3 times upper limit of normal.
- Subjects who are receiving and cannot discontinue cisapride, astemizole, terfenadine, barbiturates, phenytoin, or carbamazepine (The concentrations of these drugs may increase during clarithromycin therapy and/or lead to reduced availability of doxycycline).
- Subjects who are currently enrolled on other investigational drug trials or receiving investigational agents.
- Subjects who have been previously randomized into this study.
- Severe physical or psychiatric co-morbidity that interferes with participation in the study protocol, including previous medical diagnosis of rheumatic conditions, chronic fatigue syndrome or chronic pain conditions as well as insufficient command of the Dutch language.
- Co-morbidity that could (partially) account for the symptoms of the subject (e.g. vitamin B12 deficiency, anemia, hypothyroidism).
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01207739
Locations
| Netherlands | |
| Radboud University Nijmegen Medical Centre | |
| Nijmegen, Netherlands, 6500 HB | |
| Sint Maartenskliniek | |
| Nijmegen, Netherlands, 6522 JV | |
Sponsors and Collaborators
Radboud University
Sint Maartenskliniek
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
| Principal Investigator: | Bart-Jan Kullberg, Prof., M.D. | Radboud University |
Publications of Results:
Other Publications:
| Responsible Party: | Radboud University |
| ClinicalTrials.gov Identifier: | NCT01207739 History of Changes |
| Other Study ID Numbers: |
PLEASE NL-27344.091.09 ( Other Grant/Funding Number: ZonMW ) 2009-010939-40 ( EudraCT Number ) |
| First Posted: | September 23, 2010 Key Record Dates |
| Last Update Posted: | September 8, 2016 |
| Last Verified: | September 2016 |
Keywords provided by Radboud University:
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Prolonged antibiotic treatment in Lyme disease Doxycycline Clarithromycin Hydroxychloroquine |
Additional relevant MeSH terms:
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Lyme Disease Borrelia Infections Gram-Negative Bacterial Infections Bacterial Infections Tick-Borne Diseases Spirochaetales Infections Anti-Bacterial Agents Clarithromycin Doxycycline Ceftriaxone Antibiotics, Antitubercular Hydroxychloroquine |
Anti-Infective Agents Antitubercular Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Antimalarials Antiprotozoal Agents Antiparasitic Agents Antirheumatic Agents |