Form 0920 Mycoplasma genitalium Treatment Failure Registry Case Re

Form Approved 0MB No. 0920-20OT Expiration Date: XX/XX/XXXX

Mycoplasma genitalium Treatment Failure Registry

CASE REPORT FORM

The purpose of this form is to collect clinical information on cases of Mycoplasma genitalium that fail antibiotic therapy Public reporting burden of this collection of information is estimated to average 30 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSDR Reports Clearance Officer; 1600 Clifton Road NE, MS D-74, Atlanta, Georgia 30333; Attn: OMB-PRA (0920-New) All reported information will be maintained in the strictest confidence. Questions? Contact xxx at [email protected] Confidentiality Note: The information in this form includes confidential information intended only for the use of the individual or entity named below. If the reader of this form is not the intended recipient, you are hereby notified that any dissemination, distribution or copy of this form is strictly prohibited and may result in civil and criminal penalties under federal law. If you have received this form in error, please immediately notify us immediately at the number above. PLEASE COMPLETE BY / / and fax to our confidential fax line (xxx)xxx-xxxx.
PROVIDER INFORMATION:
Provider Name				Provider Phone #			Provider Fax #
Provider Email Address				Practice/Clinic Name
Address				City			State		Zip
PATIENT UNIQUE IDENTIFIER* (First Initial, Last initial, 2-digit year of birth, last 4 digits of Medical Record Number) Example: John Smith, born 1973, MRN 1234567 = JS734567
PATIENT AGE:			PATIENT PREVIOUSLY REPORTED TO THE REGISTRY?  Yes  No
PATIENT DEMOGRAPHIC INFORMATION:
1. Race (check all that apply) Unknown White Asian	Black or African American American Indian / Alaska Native Native Hawaiian / Other Pacific Islander Other ­­­­­_____________________				3a. Sex assigned at birth Male Female 3b. Gender identity Male Female Transgender female Transgender male Gender non-binary Unknown
2. Ethnicity Unknown  Hispanic / Latino  Not Hispanic / Latino
4. Gender of sex partners in past year (check all that apply) Male □ Gender non-binary Female □ Unknown Transgender female Transgender male					5. HIV Status HIV-positive HIV-negative Unknown/Never tested
DIAGNOSTICS/ TREATMENT
Indication for M. genitalium testing (check all that apply): 1) Symptoms: Urogenital (e.g., discharge, dysuria) Anorectal (tenesmus, discharge, pain) Pelvic/abdominal (pain, dyspareunia) 2) Clinical Syndrome (w/ objective findings): Urethritis (documented discharge or pyuria) Cervicitis (discharge, friability, + swab test) PID Proctitis Other _________________
M. genitalium diagnosis confirmed with nucleic acid amplification test?  Yes  No  Unknown		Laboratory performing M. genitalium testing. (e.g., Quest, LabCorp, name of hospital, etc) ­­­­­______________________________				Testing for macrolide resistance performed? Yes  No If yes, mutation detected? Yes  No
Testing for fluroquinolone resistance performed? Yes  No If yes, mutations detected: S83I parC unspecified
Date of initial treatment initiation / /  Unknown		Date of 2nd course treatment initiation / /  Un­­­­­­­­known				Date of 3rd course treatment initiation / /  Unknown
Initial treatment prescribed (check all that apply), and dose/frequency/duration (e.g., doxycycline 100 mg po BID x 7 days)  Azithromycin _________________x days  Doxycycline _________________x days  Moxifloxacin ­­­­­­­­­­­ _________________x days  Minocycline ­­­­­­­­­­­ _________________x days  Other ­­­­­­­­­­­ _________________x days		Second treatment prescribed (check all that apply), and dose/frequency/duration  Azithromycin _________________x days  Doxycycline _________________x days  Moxifloxacin ­­­­­­­­­ _________________x days  Minocycline­­­­­­­­­­­ _________________x days Other _________________x days				Third treatment prescribed (check all that apply), and dose/frequency/duration  Azithromycin _________________x days  Doxycycline _________________x days  Moxifloxacin ­­­­­­­­­­­ _________________x days  Minocycline ­­­­­­­­­­­ _________________x days  Other ­­­­­­­­­­­ _________________x days
Response to initial therapy (check all that apply)  Persistent symptoms (subjective only)  Persistent symptoms (subjective) plus objective findings (e.g, discharge, +urine dip, elevated WBC)  Positive NAAT post treatment		Response to second therapy (check all that apply)  Resolution of symptoms  Persistent symptoms (subjective only)  Persistent symptoms (subjective & objective findings, e.g., discharge, +urine dip, elevated WBC)  Positive NAAT post treatment				Response to third therapy (check all that apply)  Resolution of symptoms  Persistent symptoms (subjective only)  Persistent symptoms (subjective and objective findings, e.g., discharge, +urine dip, elevated WBC)  Positive NAAT post treatment
Date of 4th course treatment initiation / /  Unknown		Date of 5th course treatment initiation / /  Un­­­­­­­­known				Date of 6th course treatment initiation / /  Unknown
Fourth treatment prescribed (check all that apply), and dose/frequency/duration  Azithromycin _________________x days  Doxycycline _________________x days  Moxifloxacin ­­­­­­­­­­­ _________________x days  Minocycline ­­­­­­­­­­­ _________________x days  Other ­­­­­­­­­­­ _________________x days		Fifth treatment prescribed (check all that apply), and dose/frequency/duration  Azithromycin _________________x days  Doxycycline _________________x days  Moxifloxacin ­­­­­­­­­­­ _________________x days  Minocycline ­­­­­­­­­­­ _________________x days  Other ­­­­­­­­­­­ _________________x days				Sixth treatment prescribed (check all that apply), and dose/frequency/duration  Azithromycin _________________x days  Doxycycline _________________x days  Moxifloxacin ­­­­­­­­­­­ _________________x days  Minocycline ­­­­­­­­­­­ _________________x days  Other ­­­­­­­­­­­ _________________x days
Response to fourth therapy (check all that apply)  Resolution of symptoms  Persistent symptoms (subjective only)  Persistent symptoms (subjective and objective findings, e.g., discharge, +urine dip, elevated WBC)  Positive NAAT post treatment		Response to fifth therapy (check all that apply)  Resolution of symptoms  Persistent symptoms (subjective only)  Persistent symptoms (subjective and objective findings, e.g., discharge, +urine dip, elevated WBC)  Positive NAAT post treatment				Response to sixth therapy (check all that apply)  Resolution of symptoms  Persistent symptoms (subjective only)  Persistent symptoms (subjective and objective findings, e.g., discharge, +urine dip, elevated WBC)  Positive NAAT post treatment
PARTNER TREATMENT
Does patient have a primary sexual partner? Yes  No  Unknown If yes, was the primary partner symptomatic? Yes  No  Unknown Was the primary partner treated? Yes  No  Unknown If yes, was the primary partner examined by you or another clinician prior to treatment? Yes  No  Unknown
Partner treatment prescribed (check all that apply), and dose/frequency/duration  Azithromycin _________________x days  Doxycycline _________________x days  Moxifloxacin ­­­­­­­­­­­ _________________x days  Minocycline ­­­­­­­­­­­ _________________x days  Other ­­­­­­­­­­­ _________________x days		Partner response to therapy (Check all that apply)  Resolution of symptoms  Persistent symptoms (subjective only)  Persistent symptoms (subjective and objective findings, e.g., discharge, +urine dip, elevated WBC)  Positive NAAT post treatment  Unknown, partner not examined If partner has persistent symptoms or NAAT following therapy, please complete a separate case report form for the partner.
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Version date 05/08/2020