Chlamydia Trachomatis InfectionRCTNCT03862495

Genital CT Treatment to Pregnant Women to Prevent Adverse Pregnancy Outcomes: A Pilot RCT

A study testing C. trachomatis and N. gonorrhoeae, Azithromycin and Partner notification and treatment in people with Chlamydia Trachomatis Infection, run by University of North Carolina, Chapel Hill at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study aims to identify the relationship between genital C. trachomatis and adverse pregnancy outcomes, and investigate whether screening and treatment of genital C. trachomatis in pregnant women can reduce adverse pregnancy outcomes. Read more about this study

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Chlamydia Trachomatis Infection
What is being tested?: C. trachomatis and N. gonorrhoeae, Azithromycin and Partner notification and treatment
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: 2 sitesChina
Study dates: 21 May 2020to 3 Mar 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

pregnant women on their first visit to the hospital (regardless of gestational age);
aged 18 or above;
agree to participate and sign an informed consent.

Who cannot join

systemic or topical vaginal antibiotics use within 2 weeks prior to the first perinatal visit;
comorbidities that are known to be related to adverse pregnancy outcomes (e.g., diabetes and hypertension);
diagnosed adverse pregnancy outcomes at recruitment (e.g., stillbirth); Women with a previous history of CT or NG and women with a prior adverse outcome will not be excluded. Instead, the investigators will conduct sub-analysis and check whether the intervention has different effects on different groups of pregnant women.

Trial locations and contacts

2 sites in 1 country.

China2 sites

Dermatology Hospital of Southern Medical Hospital
Guangzhou, Guangdong
Nanhai Hospital of Southern Medical University
Guangzhou, Guangdong

Other trials in China

About this study

Official title: Genital Chlamydia Trachomatis Treatment to Pregnant Women to Prevent Adverse Pregnancy Outcomes: A Randomized Control Trial Pilot Study

Approximately 200 pregnant women from Nanhai Hospital of Southern Medical University in Guangzhou, China will be enrolled and randomized to the intervention or control group.

Read the detailed description

Women recruited for the study will be randomized to the intervention or control groups. Women in the intervention group will be tested in real time for C. trachomatis and Neisseria gonorrhoeae. Patients who test positive for either infection will be linked to physicians at the Center for treatment. For the control group, women will be tested immediately after childbirth or in the event of an adverse pregnancy outcome. In the event of a positive test result, a confirmation test will be run and if positive, the patient will be referred for treatment. The endpoint of the study is defined as either the occurrence of an adverse pregnancy outcome or delivery of a newborn.

Qualitative in-depth interviews will also be conducted with 20 of the women to explore their opinions, attitudes and feedback on the study process. University of North Carolina at Chapel Hill (UNC) investigators will work with the Nanhai Hospital of Southern Medical University and staff at Dermatology Hospital of Southern Medical University to oversee the study.

Conditions: Chlamydia Trachomatis Infection
Being tested: C. trachomatis and N. gonorrhoeae, Azithromycin, Partner notification and treatment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

C. trachomatis and N. gonorrhoeaeDiagnostic test
Also called Roche Cobas Z480
In vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhea in patient specimens utilizing amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of C. trachomatis and N. gonorrhoeae.
AzithromycinDrug
Also called Zithromax, Zmax
Azithromycin 1g administered as a single oral dose
Partner notification and treatmentOther
Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses

Study groups in NCT03862495
Study group	Role	What they receive
Chlamydia Screening and Treatment	Experimental	At the time of recruitment and prior to delivery, this group will have immediate testing for C. trachomatis and N. gonorrhoeae. Physicians will notify C. trachomatis positive results to pregnant women and suggest them and their spouses to get treated according to the national standard treatment plan for Chlamydia (Azithromycin 1g, single oral administration). Patients will be followed up to confirm cure of C. trachomatis in one month. Partner notification and treatment will be suggested for pregnant women who test positive for Chlamydia. Receives: Diagnostic Test: C. trachomatis and N. gonorrhoeae; Drug: Azithromycin; Other: Partner notification and treatment
Control	Experimental	This group will have testing after delivery (immediately following childbirth) or in the event of an adverse pregnancy outcome for C. trachomatis and N. gonorrhoeae. In the event of a positive test, patients will be informed of the positive test results the same way as the intervention group. Specific treatment options will be the same as the intervention group. Physicians will ask patients to return to Nanhai Hospital one month after treatment for test of cure. Partner notification and treatment will be suggested for pregnant women who test positive for Chlamydia. Receives: Diagnostic Test: C. trachomatis and N. gonorrhoeae; Drug: Azithromycin; Other: Partner notification and treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

Response Rate at Recruitment
Number of women who get tested for CT and N. gonorrhoeae (NG) divided by the number of women being contacted about the study at the recruitment
Measured: at the time of enrollment
Compliance to Receive CT or NG Treatment
Number of women electing to receive CT or NG treatment within 1 week after the notification of positive test results
Measured: Within 1 week after the notification of positive test results
Number of Participants Considered as Cured After Treatment
Number of women who re-tested negative either at 1 or at 3 months after treatment divided by the number of women who received CT or NG treatment
Measured: 1 or 3 months after the treatment
Number of Participants With Adverse Pregnancy Outcomes
Number of any adverse pregnancy outcomes, including stillbirth (a baby who dies after 28 weeks of pregnancy, but before or during birth), fetal death, infant death, miscarriage (pregnancy loss between 12-28 weeks), preeclampsia (pre eclampsia: hypertension with proteinuria occurs after 20 weeks of pregnancy; eclampsia: convulsions that occur on the basis of preeclampsia and cannot be explained by other reasons), low birth weight (<2500g), smaller than gestational age, preterm birth (<37 gestational weeks), birth defect, and premature rupture of membrane (spontaneous rupture of fetal membranes before delivery, classified into full-term PROM and preterm PROM based on the gestational age) in both groups through study completion.
Measured: through study completion, an average of 1 year

Secondary outcomes (3)

Number of Participants Considered as Cured at 1 Month After the Treatment
Number of women who get tested for CT and NG 1 month after the treatment divided by the number of women who receive CT or NG treatment.
Measured: 1 month after the treatment
Number of Participants Considered Cured at 3 Months After the Treatment
Number of women who get tested for CT and NG 3 months after the treatment divided by the number of women who re-tested CT or NG positive at 1 month after the treatment
Measured: 3 months after the treatment
Number of People Who Completed Follow-up
Number of women who are followed-up by the end of pregnancy or in the event of adverse pregnancy outcomes divided the number of women who are enrolled at the recruitment.
Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 May 20203 Mar 2024

First posted5 Mar 2019
Study start21 May 2020
Primary completion3 Mar 2024
Study completion3 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chlamydia Trachomatis InfectionStudies of the same condition, open and under way.
More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Model description: Pilot Randomized Controlled Trial
Masking: None (open label)
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03862495
Sponsor's protocol ID: 18-1168
Acronym: RCT
Status last verified: Feb 2023
First submitted: 22 Feb 2019
Last updated: 5 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Chlamydia Trachomatis Infection, Neisseria Gonorrhoeae Infection
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Outcomes From Point-of-Care Sexually Transmitted Infection (STI) Testing in an Urban Sexual Health Clinic: A Randomized Trial
Neisseria Gonorrhoeae Infection, Chlamydia Trachomatis Infection
Recruiting
A Seek, Test, and Treat Intervention to Reduce Chlamydia Trachomatis Disparities
Chlamydia, Gonorrhea
Recruiting
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All Chlamydia Trachomatis Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Genital Chlamydia Trachomatis Treatment to Pregnant Women to Prevent Adverse Pregnancy Outcomes: A Randomized Control Trial Pilot Study
ClinicalTrials.gov ID: NCT03862495
Acronym / sponsor ID: RCT / 18-1168
Conditions: Chlamydia Trachomatis Infection
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: University of North Carolina, Chapel HillUniversity, hospital or other
Collaborators: Southern Medical University, China
Study start: 21 May 2020 (actual)
Primary completion: 3 Mar 2024 (actual)
Study completion: 3 Mar 2024 (actual)
First posted: 5 Mar 2019 (actual)
Results: Posted 5 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Approximately 200 pregnant women from Nanhai Hospital of Southern Medical University in Guangzhou, China will be enrolled and randomized to the intervention or control group.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Pilot Randomized Controlled Trial

Arm	Type	Receives
Chlamydia Screening and Treatment	Experimental	Diagnostic Test: C. trachomatis and N. gonorrhoeae, Drug: Azithromycin, Other: Partner notification and treatmentAt the time of recruitment and prior to delivery, this group will have immediate testing for C. trachomatis and N. gonorrhoeae. Physicians will notify C. trachomatis positive results to pregnant women and suggest them and their spouses to get treated according to the national standard treatment plan for Chlamydia (Azithromycin 1g, single oral administration). Patients will be followed up to confirm cure of C. trachomatis in one month. Partner notification and treatment will be suggested for pregnant women who test positive for Chlamydia.
Control	Experimental	Diagnostic Test: C. trachomatis and N. gonorrhoeae, Drug: Azithromycin, Other: Partner notification and treatmentThis group will have testing after delivery (immediately following childbirth) or in the event of an adverse pregnancy outcome for C. trachomatis and N. gonorrhoeae. In the event of a positive test, patients will be informed of the positive test results the same way as the intervention group. Specific treatment options will be the same as the intervention group. Physicians will ask patients to return to Nanhai Hospital one month after treatment for test of cure. Partner notification and treatment will be suggested for pregnant women who test positive for Chlamydia.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

pregnant women on their first visit to the hospital (regardless of gestational age);
aged 18 or above;
agree to participate and sign an informed consent.

Key exclusion criteria (3 listed)

systemic or topical vaginal antibiotics use within 2 weeks prior to the first perinatal visit;
comorbidities that are known to be related to adverse pregnancy outcomes (e.g., diabetes and hypertension);
diagnosed adverse pregnancy outcomes at recruitment (e.g., stillbirth); Women with a previous history of CT or NG and women with a prior adverse outcome will not be excluded. Instead, the investigators will conduct sub-analysis and check whether the intervention has different effects on different groups of pregnant women.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
C. trachomatis and N. gonorrhoeaeAlso: Roche Cobas Z480In vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhea in patient specimens utilizing amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of C. trachomatis and N. gonorrhoeae.	Diagnostic test	Chlamydia Screening and Treatment, Control
AzithromycinAlso: Zithromax, ZmaxAzithromycin 1g administered as a single oral dose	Drug	Chlamydia Screening and Treatment, Control
Partner notification and treatmentPregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses	Other	Chlamydia Screening and Treatment, Control

Primary outcome

Response Rate at Recruitment
Time frame: at the time of enrollment
Number of women who get tested for CT and N. gonorrhoeae (NG) divided by the number of women being contacted about the study at the recruitment
Compliance to Receive CT or NG Treatment
Time frame: Within 1 week after the notification of positive test results
Number of women electing to receive CT or NG treatment within 1 week after the notification of positive test results
Number of Participants Considered as Cured After Treatment
Time frame: 1 or 3 months after the treatment
Number of women who re-tested negative either at 1 or at 3 months after treatment divided by the number of women who received CT or NG treatment
Number of Participants With Adverse Pregnancy Outcomes
Time frame: through study completion, an average of 1 year
Number of any adverse pregnancy outcomes, including stillbirth (a baby who dies after 28 weeks of pregnancy, but before or during birth), fetal death, infant death, miscarriage (pregnancy loss between 12-28 weeks), preeclampsia (pre eclampsia: hypertension with proteinuria occurs after 20 weeks of pregnancy; eclampsia: convulsions that occur on the basis of preeclampsia and cannot be explained by other reasons), low birth weight (<2500g), smaller than gestational age, preterm birth (<37 gestational weeks), birth defect, and premature rupture of membrane (spontaneous rupture of fetal membranes before delivery, classified into full-term PROM and preterm PROM based on the gestational age) in both groups through study completion.

3 secondary outcomes

Number of Participants Considered as Cured at 1 Month After the Treatment
Time frame: 1 month after the treatment
Number of Participants Considered Cured at 3 Months After the Treatment
Time frame: 3 months after the treatment
Number of People Who Completed Follow-up
Time frame: through study completion, an average of 1 year

Results and safety

Results posted to the registry on 5 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Chlamydia Screening and Treatment	100	63
Control	100	65

Primary outcome: Response Rate at Recruitment

Time frame: at the time of enrollment. Count of participants. Unit: Participants

Measure	Chlamydia Screening and Treatment n = 100	Control n = 100
Value	100	100

Primary outcome: Compliance to Receive CT or NG Treatment

Time frame: Within 1 week after the notification of positive test results. Count of participants. Unit: Participants

Measure	Chlamydia Screening and Treatment n = 12	Control n = 3
Value	3	1

Population analysed: Out of the 100 participants screened for each arm, 12 in the Chlamydia group tested positive and 3 in the Control group tested positive.

Primary outcome: Number of Participants Considered as Cured After Treatment

Time frame: 1 or 3 months after the treatment. Count of participants. Unit: Participants

Measure	Chlamydia Screening and Treatment n = 3	Control n = 1
Value	0	1

Population analysed: Out of the 100 participants screened for each arm, 3 in the Chlamydia group were treated and 1 in the Control group was treated.

Primary outcome: Number of Participants With Adverse Pregnancy Outcomes

Time frame: through study completion, an average of 1 year. Number. Unit: participants

Measure	Chlamydia Screening and Treatment n = 63	Control n = 65
Value	21	22

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Through study completion, an average of 1 year.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Maternal Chlamydia Screening and Treatment	0 of 65 (0%)	5 of 65 (7.7%)	0 of 65
Fetus or Infant of Mother Receiving Chlamydia Screening and Treatment	0 of 65 (0%)	21 of 65 (32.3%)	0 of 65
Maternal Control	0 of 63 (0%)	0 of 63 (0%)	0 of 63
Fetus or Infant of Mother Receiving Control	0 of 63 (0%)	22 of 63 (34.9%)	0 of 63

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

Related trials for Chlamydia Trachomatis Infection

RecruitingPhase 1
Phase 1 Study of Chlamydia Trachomatis mRNA Vaccine in Adults.
Chlamydia Trachomatis Immunization
Not yet recruiting
Optimizing Antibiotic Prescription in STI Clinics Using Rapid POCT
Chlamydia Trachomatis Infection, Neisseria Gonorrhoeae Infection
Not yet recruiting
Outcomes From Point-of-Care Sexually Transmitted Infection (STI) Testing in an Urban Sexual Health Clinic: A Randomized Trial
Neisseria Gonorrhoeae Infection, Chlamydia Trachomatis Infection
Recruiting
A Seek, Test, and Treat Intervention to Reduce Chlamydia Trachomatis Disparities
Chlamydia, Gonorrhea
Recruiting
Improving Maternal and Child Health Through Point-of-care STI Testing
Treponema Pallidum Infection, Chlamydia Trachomatis Infection

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Weiming Tang, MD, PhD principal investigator

University of North Carolina, Chapel Hill

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response Rate at Recruitment (time frame: at the time of enrollment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03862495.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2024.