Comparison of the Efficacy of the Single Dose Azithromycin and in Combination with Moxifloxacin Based on the Syndromic and Etiologic Diagnostic Methods on Chlamydial Cervicitis
Determination and comparison of the efficacy of the single dose Azithromycin and in combination with Moxifloxacin Based on the syndromic and etiologic diagnostic methods on chlamydial cervicitis
Design
Clinical trial with control group; individual based; with parallel groups, one blind, randomized, phase 3 of the trial
Settings and conduct
18-35 years old women referring to Booali clinic in Amol with cervicitis complaints if they have inclution criteria, after encoding with random assignment by Random application software are divided into 4 experimental groups and depending on their allocation to each group, they are diagnosed and treated. At 1 and 3 months after the start of treatment, the samples are referred for follow up. Finally, in 120 samples (30 samples per group), according to the appropriate statistical tests, the results of the comparison of each of the four groups and the results of the diagnostic value of both diagnostic methods, efficacy and side effects of the two drugs are studied.
Participants/Inclusion and exclusion criteria
Women aged 18-35; Having just one partner in the last two months; Not intake of drugs that interfere with Azithromycin or Moxifloxacin; Not Pregnancy; Not lactation; Absence of abnormal uterine bleeding
Intervention groups
Control group: Oral Azithromycin and syndromic diagnostic method
Intervention group 1: Combination therapy of oral Azithromycin and oral Moxifluxacin and syndromic diagnostic method
Intervention group 2: Combination therapy of oral Azithromycin and oral Moxifluxacin and ethiologic diagnostic method; Real-Time PCR
Intervention group 3: Oral Azithromycin and ethiologic diagnostic method; Real-Time PCR
Main outcome variables
Status of patient's complaints; Status of clinical findings; lab results
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100130003226N16
Registration date:2019-01-16, 1397/10/26
Registration timing:registered_while_recruiting
Last update:2019-01-16, 1397/10/26
Update count:0
Registration date
2019-01-16, 1397/10/26
Registrant information
Name
Mahrokh Dolatian
Name of organization / entity
Shahid Beheshti University of Medical Scenices
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 2512
Email address
m_dolatian@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-05-22, 1398/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Efficacy of the Single Dose Azithromycin and in Combination with Moxifloxacin Based on the Syndromic and Etiologic Diagnostic Methods on Chlamydial Cervicitis
Public title
Comparison of the Efficacy of the Azithromycin and in Combination with Moxifloxacin on Chlamydial Cervicitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women aged 18-35
Having just one partner in the last two months
Married and sexually active
Clinical diagnosis of chlamydial cervicitis and confirmation of diagnosis by Real-Time PCR (in the etiological diagnostic group of PCR)
Syndrome diagnosis of chlamydial cervicitis includes diagnosis based on a set of symptoms that can be found during the history and examination of the patient (in the diagnostic syndromic group)
Exclusion criteria:
Concomitant use of drugs that interfere with azithromycin or moxifluxacin
Having a history of allergy to Quinolones or Macrolides
Use of intrauterine device
pregnancy and pregnancy intent in the next 3 months
lactation
participating in other studies and drug use over the past 4 weeks
abnormal uterine bleeding
The participants do not know in which group are assigned. The drug is delivered to the participants in sealed envelopes
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
University Building No. 2, Sixth Floor, Parvaneh Str., Yemeni Ave, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2018-07-29, 1397/05/07
Ethics committee reference number
IR.SBMU. RETECH. REC. 1397. 309
Health conditions studied
1
Description of health condition studied
Chlamydial Cervicitis
ICD-10 code
A56.2
ICD-10 code description
Chlamydial infection of genitourinary tract, unspecified
Primary outcomes
1
Description
status of patient's complaints includes vaginal discharge, abdominal pain, painful intercourse
Timepoint
One month and three month after treatment
Method of measurement
Complaint checklist
2
Description
Status of clinical findings includes swollen and fragile cervix, and mucopurulent secretions
Timepoint
One month and three month after treatment
Method of measurement
Clinical findings check list
3
Description
lab results
Timepoint
One month and three month after treatment
Method of measurement
Nucleic Acid Amplification Test (Polymerase Chain Reaction)
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Oral Azithromycin and syndromic diagnostic method. Azithromycin 1 g oral single dose (two 500mg) . Azithromycin can be taken with food, after or before meals. This is Dr Abeidi's Pharmaceutical Drug Company (IRC: 2366570648796929 / GTIN: 06260154636041). Syndromic diagnosis: Detection based on a set of symptoms found during a patient's history and examination
Category
Treatment - Drugs
2
Description
Intervention group: Combination therapy of oral azithromycin and oral moxifloxacin and syndromic diagnostic method. Azithromycin 1 g oral single dose (two 500mg). Moxifloxacin tablets 400 mg daily for 7 days. This pill is manufactured by Drug Pakhsh factories (IRC: 2493594828199352 / GTIN: 06260132430517). On the first day of treatment, oral azithromycin 1000 mg is administered as a single dose. Then the treatment is continued from day two to eight with oral moxifloxacin 400 mg once daily for 7 days. Syndromic diagnosis: Detection based on a set of symptoms found during a patient's history and examination
Category
Treatment - Drugs
3
Description
Intervention group: Combination therapy of oral azithromycin and oral moxifloxacin and ethiologic diagnostic method; Real-Time PCR. Azithromycin 1 g oral single dose (two 500mg) and Moxifloxacin tablets 400 mg daily for 7 days. On the first day of treatment, oral azithromycin 1000 mg is administered as a single dose. Then the treatment is continued from day two to eight with oral moxifloxacin 400 mg once daily for 7 days. Ethiologic Diagnostic Method Real-Time PCR : A liquid-based sample is used for NAAT to study chlamydia.
Category
Treatment - Drugs
4
Description
Intervention group: Oral Azithromycin and ethiologic diagnostic method; Real-Time PCR. Azithromycin 1 g oral single dose (two 500mg). Ethiologic Diagnostic Method Real-Time PCR : A liquid-based sample is used for NAAT to study chlamydia.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Booali clinic
Full name of responsible person
Doctor Masood Kamyab
Street address
No 1., Taleb amoli Ave., Booali clinic
City
Amol
Province
Mazandaran
Postal code
4616979457
Phone
+98 11 4428 4260
Email
kamyabmasood@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Iran-tehran-University Building No. 2 of ShahidBeheshti University of Medical Sciences, Parvaneh Str., Yemeni Ave, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Fax
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahrokh Dolatian
Position
Vice-Chancellor of Research, Faculty of Nursing and Midwifery
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Valiasr Str., intersection of Niyayesh
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 218865536671
Fax
+98 21 8820 2521
Email
sbnmf@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahrokh Dolatian
Position
Vice-Chancellor of Research, Faculty of Nursing and Midwifery
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Valiasr Str., intersection of Niyayesh
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 218865536671
Fax
+98 21 8820 2521
Email
sbnmf@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Farnaz Mohammadzadeh
Position
Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No. 28, Aftab 38 Ave., Imam khomaini Str.,
City
Amol
Province
Mazandaran
Postal code
4616818591
Phone
+98 11 4424 0370
Email
farnaz.mohammadzade@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available