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Symptomatic Management of Lyme Arthritis

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04038346
Recruitment Status : Recruiting
First Posted : July 30, 2019
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
Desiree Neville, MD, University of Pittsburgh

Brief Summary:

Lyme arthritis resolves with appropriate antimicrobial treatment in a majority of patients, but 10-20% of patients develop antibiotic-refractory Lyme arthritis with prolonged arthritis symptoms and treatment courses. Excessive up-regulation of the inflammatory process has been shown in patients with antibiotic-refractory Lyme arthritis. The over-expressed pro-inflammatory cell mediators are downstream of NSAID inhibition, which would suggest initial inflammatory inhibition may be beneficial in these patients. While NSAIDs are known to reduce pro-inflammatory cell mediators early in the course of inflammation, research has shown that there are other cytokines that play a role in the healing after inflammation that are also inhibited by NSAIDs, and that NSAID use can delay healing.

It is not known if scheduled NSAID therapy will reduce, increase, or have no effect on the occurrence of refractory Lyme arthritis cases. The hypothesis of the study is that prescribing scheduled NSAIDs at the time of diagnosis of Lyme arthritis can prevent the development of the excessive inflammatory phase and decrease the number of patients with antibiotic-refractory Lyme arthritis, or at least decrease the duration of persistent Lyme arthritis symptoms.

The pilot study design randomizes patients to scheduled NSAIDs, scheduled acetaminophen, or scheduled NSAIDs x 1 week than acetaminophen. Primary outcomes are duration of arthritis symptoms, number of refractory cases, side effects and compliance.


Condition or disease Intervention/treatment Phase
Lyme Arthritis Lyme Disease Arthritis Drug: Naproxen Drug: Acetaminophen Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, randomized, controlled, non blinded
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Symptomatic Management of Lyme Arthritis
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis

Arm Intervention/treatment
Experimental: NSAID
Naproxen at weight based standard dose given bid daily until symptoms resolve
Drug: Naproxen
Patients will be randomized to an NSAID (naproxen)
Other Name: naprosyn, aleve, anaprox

Active Comparator: Acetaminophen
Acetaminophen at weight based standard dose given qid until symptoms resolve
Drug: Acetaminophen
Patients will be randomized to acetaminophen
Other Name: tylenol

Experimental: NSAID first, then Acetaminophen
Naproxen at weight based standard dose given bid for one week, then acetaminophen at weight based standard dose given qid until symptoms resolve
Drug: Naproxen
Patients will be randomized to an NSAID (naproxen)
Other Name: naprosyn, aleve, anaprox

Drug: Acetaminophen
Patients will be randomized to acetaminophen
Other Name: tylenol

No Intervention: Standard Care
Symptom observation only



Primary Outcome Measures :
  1. Change in the degree of joint pain determined by serial visual analog scale for pain via text surveys [ Time Frame: days 1, 3, 7, 10, 14, 21, 28, 60 the VAS score will be collected, time to symptom resolution will be recorded ]
    0-100 scale (no pain to worst pain - higher score, worse outcome), slide bar in text survey, VAS score rate of change will be compared between treatment arms, and time to normalization

  2. Change in the degree of joint redness determined by serial visual analog scale for joint redness via text surveys [ Time Frame: days 1, 3, 7, 10, 14, 21, 28, 60 the VAS score will be collected, time to symptom resolution will be recorded ]
    0-100 scale (no redness to maximal redness- higher score, worse outcome), slide bar in text survey, VAS score rate of change will be compared between treatment arms, and time to normalization

  3. Change in degree of joint movement determined by serial visual analog scale for joint movement via text surveys [ Time Frame: days 1, 3, 7, 10, 14, 21, 28, 60 the VAS score will be collected, time to symptom resolution will be recorded ]
    0-100 scale (no joint movement to normal joint movement- higher score, better outcome), slide bar in text survey, VAS score rate of change will be compared between treatment arms, and time to normalization

  4. Change in degree of overall function determined by serial visual analog scale for overall function via text surveys [ Time Frame: days 1, 3, 7, 10, 14, 21, 28, 60 the VAS score will be collected, time to symptom resolution will be recorded ]
    0-100 scale (severely impaired function to normal function- higher score, better outcome), slide bar in text survey, VAS score rate of change will be compared between treatment arms, and time to normalization

  5. Time to complete symptom resolution as collected by a yes/no question on the text survey and a branching question asking the date that the symptoms were completely resolved. [ Time Frame: The branching question will appear on their text survey at any of the time points (days 1, 3, 7, 10, 14, 21, 28, 60) once they enter "yes" to symptoms completely resolved. ]
    If patient answers yes to symptoms completely resolved, they will receive a branching question to input the date. Time from diagnosis to symptom resolution will be compared between the treatment groups.


Secondary Outcome Measures :
  1. Change in medication compliance as determined by question in serial text survey [ Time Frame: days 1, 3, 7, 10, 14, 21, 28, 60 (collected until symptom resolution) ]
    Parents enter number of days patient has taken the medication in the past day as well as per day since the last survey in two questions on the text survey with their response being a drop down number list on the text survey- medication compliance will be compared to the number of doses that would be full compliance for that treatment arm

  2. Development of medication side effects as determined by question in serial text survey [ Time Frame: days 1, 3, 7, 10, 14, 21, 28, 60 (collected until symptom resolution) ]
    survey asks parents to describe any medication side effects they feel their child has had - descriptive outcome only

  3. Other medications taken as determined by question in serial text survey [ Time Frame: days 1, 3, 7, 10, 14, 21, 28, 60 (collected until symptom resolution) ]
    Parents are asked to list any medications in addition to their study drug and antibiotic that their child has taken- descriptive outcome only

  4. Fever as determined by question in serial text survey [ Time Frame: days 1, 3, 7, 10, 14, 21, 28, 60 (collected until symptom resolution) ]
    Parents are asked if their child had fever in the 24 hours prior to taking the text survey, duration of fever compared between treatment arms


Other Outcome Measures:
  1. Need for further care as determined by medical record review as number of visits in the system for Lyme arthritis symptoms [ Time Frame: 30 days, 60 days, 120 days, 1 year ]
    Mean repeat medical visits for Lyme arthritis will be compared between treatment arms based on medical record review



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Arthritis
  • Undergoing Lyme disease testing (Lyme test positive)

Exclusion Criteria:

  • Patients will be secondarily withdrawn from analysis and instructed to stop study medication if their Lyme test is negative.

Underlying diagnosis of rheumatoid or recurrent arthritis Already on scheduled NSAIDs

Anything that restricts the prescription of naproxen or acetaminophen:

  • Hypersensitivity to naproxen (for example: anaphylactic reactions, serious skin reactions) or any component of the formulation; history of aspirin induced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs, underlying kidney or liver impairment
  • Already taking daily NSAIDs (naproxen or ibuprofen) or daily acetaminophen
  • Hypersensitivity to acetaminophen or any component of the formulation; severe liver impairment or severe active liver disease

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): NCT04038346


Contacts
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Contact: Desiree NW Neville, MD 412-692-7692 desiree.neville@chp.edu

Locations
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United States, Pennsylvania
Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Neville, MD       desiree.neville@chp.edu   
Principal Investigator: Desiree Neville, MD         
Sponsors and Collaborators
Desiree Neville, MD
Investigators
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Principal Investigator: Desiree NW Neville, MD University of Pittsburgh

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Responsible Party: Desiree Neville, MD, Assistant Professor of Pediatric Emergency Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT04038346    
Other Study ID Numbers: PRO18110151
First Posted: July 30, 2019    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Desiree Neville, MD, University of Pittsburgh:
Lyme Arthritis
Lyme
Lyme Disease
Arthritis
NSAID
Additional relevant MeSH terms:
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Lyme Disease
Arthritis
Joint Diseases
Musculoskeletal Diseases
Borrelia Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Tick-Borne Diseases
Spirochaetales Infections
Acetaminophen
Naproxen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action