0920 Mycoplasma genitalium Treatment Failure Registry Case Re

Mycoplasma Genitalium Treatment Failure Registry

Att 4 Case Report Form_MG

OMB: 0920-1326

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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.


Notes:

Version date 05/08/2020


File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
File TitlePROTOCOL FOR MONITORING IMPACT OF HPV VACCINE THROUGH CIN 2/3 IN EIP SITES
AuthorHitchcock, Cody (CDPH-CID-DCDC-STD)
File Modified0000-00-00
File Created2021-11-05

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