臨床研究等提出・公開システム

Japanese

Date of registration	June. 06, 2023
Last modified on	July. 16, 2024
Trial ID	jRCTs031230111

Scientific Title	Sitafloxacin versus moxifloxacin-based sequential treatment for Mycoplasma genitalium infections, multi-center, open-label, randomized controlled trial.
Public Title	Stafloxacin therapy against Mycoplasma genitalium infections

Contact for Scientific Queries	Name	Ando Naokatsu
	Affiliation	National Center for Global Health and Medicine
	Address	1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan
	Telephone	+81-3-3202-7181
	E-mail	nandou@hosp.ncgm.go.jp
Contact for Public Queries	Name	Naokatsu Ando
	Affiliation	National Center for Global Health and Medicine
	Address	1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan
	Telephone	+81-3-3202-7181
	E-mail	nandou@hosp.ncgm.go.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		June. 19, 2023
Actual date of first enrollment		Aug. 07, 2023
Target sample size		112
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. Patients provided an informed consent in writing. 2. Patients aged 18 years or older. 3. Patients diagnosed with Mycoplasma genitalium by urine or rectal sample
	Exclusion Criteria	1. Individuals with pregnancy 2. Individuals with a history of known hypersensitivity to sitafloxacin, doxycycline or moxifloxacin. 3. Individuals who are judged by their physicians in charge to be ineligible for any reason
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Mycoplasma genitalium
Intervention(s)		Study group 1. Sitafloxacin 200mg daily for 7 days Control group 1. Doxycycline 200mg daily for 7 days followed by moxifloxacin 400mg daily for 7 days Administration of doxycycline for up to 7 days is allowed as pre-study empiric treatment from the date of submission of the Mycoplasma genitalium test. If assigned to the study drug (sitafloxacin) group, sitafloxacin followed by pre-administration of doxycycline. If assigned to the standard drug (moxifloxacin) group, moxifloxacin will be administered following 7 days of doxycycline. The interval between doxycycline administration and subsequent quinolone administration should not exceed 3 days.
Health Condition(s) Keyword		Urithritis, Proctitis, Sexually transmitted infections, Mycoplasma genitalium, Sitafloxacin, Moxifloxacin, Sequential therapy, ParC, GyrA
Intervention(s) Keyword		sitafloxacin, sequential therapy, moxifloxacin, doxycycline
Health Condition(s) Code		D045704
Intervention(s) Code		D016449
Primary Outcome(s)		Cure rate
Secondary Outcome(s)		Changes of bacterial load after intervention New development of resistant associated mutations after intervention

Primary Sponsor

Primary Sponsor

Primary Sponsor

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	National Center for Global Health and Medicine
Secondary Sponsor	Not applicable

Name of Certified Review Board	Certified Review Board of National Center for Global Health and Medicine
Address	1-21-1 Toyama, Shinjuku-ku Tokyo Japan, Tokyo, Tokyo
Telephone	+81-3-3202-7181
E-Mail	kenkyu-shinsa@hosp.ncgm.go.jp
Approval Status	Approval
Date of approval	Mar. 23, 2023

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
8	July. 16, 2024	(this page)	Changes
7	July. 12, 2024	Detail	Changes
6	Sept. 26, 2023	Detail	Changes
5	Sept. 04, 2023	Detail	Changes
4	Aug. 07, 2023	Detail	Changes
3	July. 18, 2023	Detail	Changes
2	June. 08, 2023	Detail	Changes
1	June. 06, 2023	Detail

List of change history