journal gyne

8/17/2019 Journal Gyne

1/17

American Society of Microbiology

2014

JI Debbie Marie R. Fermin

April 22, 2014


2/17

Bacgro!n"

• Chlamydia trachomatis – #ID

– Infertility

– $ctopic pregnancy


3/17

Rifala%il

al&o no'n a& (RM)1*4+ or ben%oa%inorifamycina ne' &emi&ynt-etic rifamycinbloc& t-e )&!b!nit in t-e R/A polymera&e

-a& a long -alf)life of approimately *0 -


4/17

Rifala%il

• #otent in vitro bacterici"al actiityagain&t . trac-omati&

• In vitro &t!"ie& -ae &-o'n t-atrifala%il -a& a &ignicantly greaterantimicrobial potency again&t .trac-omati& t-an a%it-romycin

Rot-&tein DM et al. 2003. Rifala%il an" ot-er ben%oa%inorifamycin in t-e treatment of c-lamy"ia)ba&e"per&i&tent infection&.


5/17

b5ectie

• 6o eal!ate t-e &afety an" e7cacy ofa &ingle oral a"mini&tration of 28 mgof Rifala%il compare" 'it- a &ingle

oral a"mini&tration of 1 g ofA%it-romycin


6/17

• # 9 :omen age" ; 1< year& '-o

'ere "iagno&e" 'it-!ncomplicate" genital .trac-omati& infection

•

I 9 Single oral a"mini&tration of 28mg Rifala%il an" 1 g A%it-romycin

• 9 $7cacy an" Safety of Rifala%il

•M 9 Ran"omi%e", Do!ble)Blin",

M!lticenter Safety an" $7cacySt!"y


7/17

S!b5ectInclusion Criteria Exclusion Criteria

• :omen age" ; 1< year&• /ot pregnant or lactating• '-o 'ere "iagno&e" 'it-

!ncomplicate" genital .

trac-omati& infection int-e 21 "ay& beforeran"omi%ation ba&e" on apo&itie /AA6.

• ;= epi&o"e& of .trac-omati& infection'it-in * mont-& prior toenrollment

•>ae gonorr-ea, >I?,&yp-ili&, or actie-epatiti& B or ir!&infection at t-e time ofenrollment.

•:omen '-o -a" taenantimicrobial t-erapy 'it-actiity again&t .trac-omati&, -erbal&!pplement& &!c- a& St.

Jo-n@& 'ort an" blacco-o&-, anot-er


8/17

Material& Met-o"&

• 6-e &t!"y 'a& !npo'ere" an" -a" a planne"&ample &i%e of +0 &!b5ect&,

• S!b5ect& 'ere ran"omi%e" on a 11 ba&i& to one oft-e t'o treatment gro!p&.

• 6-ere 'ere fo!r &c-e"!le" clinic i&it&, a& follo'& – ba&eline i&it C"ay 1

– i&it 2 Con "ay + to 12

– i&it =, or te&t)of)c!re C6 i&it Con "ay 22 to 2*

– an" i&it 4, or en")of &t!"y i&it Con "ay =* to 40.

– 6o maintain t-e blin", all &t!"y me"ication& 'ereoerencap&!late".


9/17

#rimary $7cacy Analy&i&

• Ba&e" on microbiological intention totreat CmI66 pop!lation – "ene" a& all ran"omi%e" &!b5ect& '-o

-a" receie" t-e &t!"y me"ication an"-a" a po&itie . trac-omati& /AA6 atba&eline


10/17

#rimary $7cacy $n"point

• rate of microbiologic c!re of .trac-omati& at t-e 6 i&it Ci&it =,"ay 22 to 2*


11/17

Safety $al!ation

• 6reatment emergent a"er&e eentC6$A$ – an a"er&e eent t-at 'a& reporte" after

t-e &!b5ect -a" been "o&e". – 6-e i&

• 6reatment)relate" 6$A$ –

"ene" a& an a"er&e eent t-at 'a&a&&e&&e" by t-e principal ine&tigator a&remotely, po&&ibly, probably, or "enitelyrelate" to t-e &t!"y "r!g.


12/17


13/17


14/17

$7cacy Re&!lt&


15/17

Safety Re&!lt&


16/17

#la&ma concentration& ofRifala%il


17/17

oncl!&ion

• Mo&t c-lamy"ia)infecte" 'omentreate" 'it- &ingle)"o&e rifala%il 'erec!re" an" t-e "r!g 'a& 'ell tolerate".

• Rifala%il remain& a promi&ing &ingle)"o&e alternatie to a%it-romycin fort-e treatment of c-lamy"ia, b!t an

a"eE!ately po'ere" &t!"y of rifala%il'ill be nece&&ary to "emon&trate t-atrifala%il i& noninferior to a%it-romycin.

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