Context

  1. Dr. Beatrice A. Golomb and her colleagues at the University of California - San Diego are conducting a new research study to identify and describe beneficial and adverse effects associated with antibiotics in the fluoroquinolone class.  Example fluoroquinolones include Cipro or Ciprodex or Proquin XR (ciprofloxacin), Levaquin or Tavanic (levofloxacin), Avelox or Vigamox (moxifloxacin), Zymar or Tequin (gatifloxacin), Floxin (ofloxacin), Zagam (sparfloxacin), Noroxin (norfloxacin), Factive (gemifloxacin), Trovan (trovafloxacin), fleroxacin, temafloxacin, pefloxacin, and Psenetrex (enoxacin). 


  2. Some reported side effects may include tendon pain, joint pain, and muscle pain; peripheral sensory neuropathy (sensations of pain, tingling, prickling, burning, “shocks,” buzzing, squeezing, or “pressure” in the arms, legs, body, or head), paresthesia; blood pressure changes, autonomic neuropathy; muscle twitching (fasciculations); insomnia or sleeping difficulty; anxiety, agitation, difficulty concentrating, hallucinations, psychosis, or seizures; mood changes including depression or suidical ideation; headaches; vision or hearing disturbances like floaters or tinnitus (ringing in the ears) or dizziness; vein problems; heart rhythm problems; nausea, diarrhea; fatigue and feelings of weakness or being tired, and more.  Tendon pain may be associated with tendinitis / tendonitis, tendinopathy, tendinosis, and tendon rupture.  Tendon, joint, or muscle pain may be felt as ankle pain, Achilles pain, heel pain, calf pain, knee pain, back pain, shoulder pain, wrist pain, thumb pain, pain in the hands, plantar fasciitis, or more.  Rheumatic, neuromuscular, and neurological side effects may cause difficulty walking, difficulty talking, difficulty swallowing, difficulty thinking.  Many of the reported adverse drug reactions (ADRs) are class effects, that is, they are common across all chemically similar antibiotics, and thus may be experienced as Cipro side effects (ciprofloxacin side effects), Levaquin side effects (levofloxacin side effects), or Avelox side effects (moxifloxacin side effects), Zymar side effects (gatifloxacin side effects), etc.  In popular usage, fluoroquinolone side effects may also be known as fluoroquinolone adverse effects, fluoroquinolone adverse reactions, or fluoroquinolone adverse drug reactions (ADR/ADRs), or fluoroquinolone toxicity. 



The Study

  1. We are currently recruiting 10,000 participants for this study who meet either of the 2 following criteria:

  2. 1. Users of fluoroquinolone antibiotics who believe that they have experienced side effects during use and/or after cessation.

  3. - or -

  4. 2. Users of fluoroquinolones antibiotics who believe that they have tolerated them without experiencing side effects or any adverse effects.

  5. Note: Participants from all countries and of all ages are accepted, but they must be fluent in the English language.


  6. If you meet the above criteria, we would like to invite you to participate in this voluntary study so that we can further research and understand the beneficial and adverse effects of fluoroquinolones and report findings to the medical community (including prescribing physicians) and the general public. 


  7. Participants will be asked to complete questionnaires.  One questionnaire is currently available for those who believe that they have tolerated the drugs without experiencing side effects or any adverse reaction.  It is expected to take approximately 20-30 minutes to complete.  A separate set of 3 questionnaires is currently available for those who believe that they have suffered adverse effects during and/or after cessation of usage.  These questionnaires will take approximately 40-90 minutes to complete; each can be completed separately with a total commitment of up to 3.5 hours.  More voluntary surveys may be available in the future.


  8. Those who tolerated fluoroquinolones may directly complete the control questionnaire or may register for the questionnaire first.  Those who experienced adverse reactions must register for questionnaires first.  Within a few days of registering, one will receive an individualized link to each questionnaire via email.  Following the link will enable the participant to resume a questionnaire from the screen where they left off, if the participant is unable to complete a questionnaire in one sitting.


  9. The results of the questionnaires will be used to prepare publications and presentations for physicians regarding the effects of fluoroquinolones.  By participating in this research, you may help educate health care providers about the effects of fluoroquinolones and help them make the best decisions regarding use and treatment. 


  10. Questionnaires are hosted and data is stored through the company Qualtrics (www.qualtrics.com), whose HIPAA-compliant software and data storage system is used by many academic and medical centers including the Mayo Clinic Health System, Scripps Health, and United Healthcare Services.  Connections with the server are secured via Secure Sockets Layer (SSL), the de facto World Wide Web standard for encryption.


  11. If you choose to participate in this research, please be assured that only aggregate data and excerpted information without personal identifiers will be used in articles, reports, and presentations generated from the research.  All personal information will be handled confidentially.  Personal health information will not be discussed over e-mail.  Compensation is currently not available for participation.


  12. For your ease, all questionnaires begin with research consent forms, but these forms may also be previewed and downloaded from the “Participant Forms“ link on the study website.  Survey responses for those under the age of 18 will require additional paper consent forms, as will responses on behalf of someone for whom the adverse reaction contributed to their death.  See the “Special Situations” page on our website or contact our office for more information.


  13. If you are interested, please review the consent forms on the study website at http://www.fqstudy.info, then proceed to the Current Questionnaires link for a list of available questionnaires.  We currently expect the questionnaires to be available through 2017. 


  14. Individuals with questions or concerns specific to the study may contact fqstudy@ucsd.edu.


  15. For ongoing personal health symptoms or problems you are experiencing, please consult your personal physician.


  16. Thank you for your interest.

  17. -The UCSD Fluoroquinolone Effects Study


  18. http://www.fqstudy.info


   

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IRB number: 130657
IRB approval date: 6/20/2013





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