CHLAMYDIA INFECTIONSNCT00607659
Immunopathogenesis of Chlamydia
An observational study of CHLAMYDIA INFECTIONS, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial summary
Sexually transmitted Chlamydia trachomatis infections are a widespread public health concern due to their prevalence and potentially devastating reproductive consequences, including pelvic inflammatory disease, infertility, and ectopic pregnancy. Read more about this study
- Who is it for?
- Ages 11 to 21 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- CHLAMYDIA INFECTIONS
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 11 to 21 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Adolescent females between 11 and 21 years of age undergoing pelvic examinations or screening for STIs at the Arkansas Children's Hospital Adolescent Center will be eligible for recruitment
Who may be able to join
- Female
- 11 to 21 years of age at the time of enrollment
- Positive for Chlamydia infections by urine or cervical PCR
- 5th Chlamydia-negative subject who fits all other inclusion criteria
- Negative pregnancy test
- Written informed consent provided
- Signed a HIPAA authorization form
- Willingness to comply with all the requirements of the protocol
Who cannot join
- Positive pregnancy test
- Negative for Chlamydia, unless 5th negative subject to be in the control group
- Any condition that in the opinion of the investigator would interfere with the ability of the potential subject to complete the study or would result in significant risk to the subject
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
About this study
Official title: Immunopathogenesis of Chlamydia Trachomatis Infection
Sexually transmitted Chlamydia trachomatis infections are a widespread public health concern due to their prevalence and potentially devastating reproductive consequences, including pelvic inflammatory disease, infertility, and ectopic pregnancy. The goal of this study is to evaluate the risk factors for adverse outcomes following genital tract infection with Chlamydia trachomatis and to evaluate whether or not the presence of C. trachomatis in the rectum act as a reservoir for infection.
Read the detailed description
Sexually transmitted Chlamydia trachomatis infections are a widespread public health concern due to their prevalence and potentially devastating reproductive consequences, including pelvic inflammatory disease, infertility, and ectopic pregnancy. The goal of this study is to evaluate the risk factors for adverse outcomes following genital tract infection with Chlamydia trachomatis and to evaluate whether or not the presence of C. trachomatis in the rectum act as a reservoir for infection. Our target population will be adolescent females age 11-21 evaluated at the ACH Adolescent Center who are undergoing pelvic examinations or urine screening for sexually transmitted infections (STIs). Laboratory specimens obtained will include cervical and rectal swabs, urine and blood specimens, as well as, chart review and comprehensive subject interviews in the initial data collection with follow-up evaluations at 3, 6, 12, 24 and 36 months for qualifying subjects
- Conditions
- CHLAMYDIA INFECTIONS
- Being tested
- No intervention, only observational
- Keywords
- Chlamydia, Chlamydia trachomatis, Adolescent Health, Female Health, Sexually Transmitted Infections, Infertility, Pelvic Inflammatory Disease
- Medical subject headings
- Chlamydia Infections, Sexually Transmitted Diseases, Infertility, Pelvic Inflammatory Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention, only observationalOther
No intervention, only observational
| Study group | Role | What they receive |
|---|---|---|
| Chlamydia Positive | Adolescent females, 11-21 years old, evaluated for pelvic examinations or STI screening will be asked to participate in this study. Participants are being asked to give us permission to collect:additional cervical or vaginal swabs, rectal swabs, blood draws where three tablespoons of blood, a urine pregnancy test, and a comprehensive health history. You may be asked to provide a urine specimen at the initial visit instead of having a cervical swab. The study team will obtain a cervical swab when you come back for your follow-up appointments. If your culture is positive for Chlamydia, you will be asked attend 3 additional follow-up appointments after 3 months, 6 months, 1 year, 2 years, and 3 years . Receives: Other: No intervention, only observational | |
| Control/Chlamydia Negative | Some participants with negative cultures will be included in this study as a control group. The same specimens, exams and blood draws will apply for those subjects with visits at 3 months, 6 months, 1 year, 2 years, and 3 years Receives: Other: No intervention, only observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the environmental and behavioral risk factors that predispose toward adverse reproductive outcomes following C. trachomatis genital tract infection in a high risk adolescent population
Measured: enrollment,3,6,12,24,36 months
Secondary outcomes (1)
Determine the prevalence of rectal C. trachomatis colonization in this high risk population and its contribution to recurrent and persistent infection and adverse reproductive outcomes such as infertility and ectopic pregnancy
Measured: enrollment,3,6,12,24,36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for CHLAMYDIA INFECTIONSStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Amy M Scurlock, M.D., Principal investigator, Arkansas Children's Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00607659
- Sponsor's protocol ID
- IRB #99416
- Other IDs
- Chaos # 1634-2, NIH 5 R01 AI051417-04
- Status last verified
- Apr 2016
- First submitted
- 8 Jan 2008
- Last updated
- 14 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Igietseme JU, Portis JL, Perry LL. Inflammation and clearance of Chlamydia trachomatis in enteric and nonenteric mucosae. Infect Immun. 2001 Mar;69(3):1832-40. doi: 10.1128/IAI.69.3.1832-1840.2001.
PubMed 11179361Cotter TW, Ramsey KH, Miranpuri GS, Poulsen CE, Byrne GI. Dissemination of Chlamydia trachomatis chronic genital tract infection in gamma interferon gene knockout mice. Infect Immun. 1997 Jun;65(6):2145-52. doi: 10.1128/iai.65.6.2145-2152.1997.
PubMed 9169744Jones RB, Rabinovitch RA, Katz BP, Batteiger BE, Quinn TS, Terho P, Lapworth MA. Chlamydia trachomatis in the pharynx and rectum of heterosexual patients at risk for genital infection. Ann Intern Med. 1985 Jun;102(6):757-62. doi: 10.7326/0003-4819-102-6-757.
PubMed 3888022Dean D, Suchland RJ, Stamm WE. Evidence for long-term cervical persistence of Chlamydia trachomatis by omp1 genotyping. J Infect Dis. 2000 Sep;182(3):909-16. doi: 10.1086/315778. Epub 2000 Aug 17.
PubMed 10950788Centers for Disease Control and Prevention (CDC). Chlamydia trachomatis genital infections--United States, 1995. MMWR Morb Mortal Wkly Rep. 1997 Mar 7;46(9):193-8.
PubMed 9072679Darville T. Chlamydia trachomatis infections in neonates and young children. Semin Pediatr Infect Dis. 2005 Oct;16(4):235-44. doi: 10.1053/j.spid.2005.06.004.
PubMed 16210104
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunopathogenesis of Chlamydia Trachomatis Infection
- ClinicalTrials.gov ID
- NCT00607659
- Acronym / sponsor ID
- IRB #99416
- Conditions
- CHLAMYDIA INFECTIONS
- Keywords
- Chlamydia, Chlamydia trachomatis, Adolescent Health, Female Health, Sexually Transmitted Infections, Infertility, Pelvic Inflammatory Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jan 2008
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 6 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sexually transmitted Chlamydia trachomatis infections are a widespread public health concern due to their prevalence and potentially devastating reproductive consequences, including pelvic inflammatory disease, infertility, and ectopic pregnancy. The goal of this study is to evaluate the risk factors for adverse outcomes following genital tract infection with Chlamydia trachomatis and to evaluate whether or not the presence of C. trachomatis in the rectum act as a reservoir for infection.
Detailed description
Sexually transmitted Chlamydia trachomatis infections are a widespread public health concern due to their prevalence and potentially devastating reproductive consequences, including pelvic inflammatory disease, infertility, and ectopic pregnancy. The goal of this study is to evaluate the risk factors for adverse outcomes following genital tract infection with Chlamydia trachomatis and to evaluate whether or not the presence of C. trachomatis in the rectum act as a reservoir for infection. Our target population will be adolescent females age 11-21 evaluated at the ACH Adolescent Center who are undergoing pelvic examinations or urine screening for sexually transmitted infections (STIs). Laboratory specimens obtained will include cervical and rectal swabs, urine and blood specimens, as well as, chart review and comprehensive subject interviews in the initial data collection with follow-up evaluations at 3, 6, 12, 24 and 36 months for qualifying subjects
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chlamydia Positive | – | Other: No intervention, only observationalAdolescent females, 11-21 years old, evaluated for pelvic examinations or STI screening will be asked to participate in this study. Participants are being asked to give us permission to collect:additional cervical or vaginal swabs, rectal swabs, blood draws where three tablespoons of blood, a urine pregnancy test, and a comprehensive health history. You may be asked to provide a urine specimen at the initial visit instead of having a cervical swab. The study team will obtain a cervical swab when you come back for your follow-up appointments. If your culture is positive for Chlamydia, you will be asked attend 3 additional follow-up appointments after 3 months, 6 months, 1 year, 2 years, and 3 years . |
| Control/Chlamydia Negative | – | Other: No intervention, only observationalSome participants with negative cultures will be included in this study as a control group. The same specimens, exams and blood draws will apply for those subjects with visits at 3 months, 6 months, 1 year, 2 years, and 3 years |
Who may qualify
- Ages
- 11 to 21 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Adolescent females between 11 and 21 years of age undergoing pelvic examinations or screening for STIs at the Arkansas Children's Hospital Adolescent Center will be eligible for recruitment
Key inclusion criteria (8 listed)
- Female
- 11 to 21 years of age at the time of enrollment
- Positive for Chlamydia infections by urine or cervical PCR
- 5th Chlamydia-negative subject who fits all other inclusion criteria
- Negative pregnancy test
Key exclusion criteria (3 listed)
- Positive pregnancy test
- Negative for Chlamydia, unless 5th negative subject to be in the control group
- Any condition that in the opinion of the investigator would interfere with the ability of the potential subject to complete the study or would result in significant risk to the subject
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 |
|---|---|---|
| No intervention, only observationalNo intervention, only observational | Other | Chlamydia Positive, Control/Chlamydia Negative |
Primary outcome
Evaluate the environmental and behavioral risk factors that predispose toward adverse reproductive outcomes following C. trachomatis genital tract infection in a high risk adolescent population
Time frame: enrollment,3,6,12,24,36 months
1 secondary outcome
Determine the prevalence of rectal C. trachomatis colonization in this high risk population and its contribution to recurrent and persistent infection and adverse reproductive outcomes such as infertility and ectopic pregnancy
Time frame: enrollment,3,6,12,24,36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
- Background: PubMed 11179361Igietseme JU, Portis JL, Perry LL. Inflammation and clearance of Chlamydia trachomatis in enteric and nonenteric mucosae. Infect Immun. 2001 Mar;69(3):1832-40. doi: 10.1128/IAI.69.3.1832-1840.2001.
- Background: PubMed 9169744Cotter TW, Ramsey KH, Miranpuri GS, Poulsen CE, Byrne GI. Dissemination of Chlamydia trachomatis chronic genital tract infection in gamma interferon gene knockout mice. Infect Immun. 1997 Jun;65(6):2145-52. doi: 10.1128/iai.65.6.2145-2152.1997.
- Background: PubMed 3888022Jones RB, Rabinovitch RA, Katz BP, Batteiger BE, Quinn TS, Terho P, Lapworth MA. Chlamydia trachomatis in the pharynx and rectum of heterosexual patients at risk for genital infection. Ann Intern Med. 1985 Jun;102(6):757-62. doi: 10.7326/0003-4819-102-6-757.
- Background: PubMed 10950788Dean D, Suchland RJ, Stamm WE. Evidence for long-term cervical persistence of Chlamydia trachomatis by omp1 genotyping. J Infect Dis. 2000 Sep;182(3):909-16. doi: 10.1086/315778. Epub 2000 Aug 17.
- Background: PubMed 9072679Centers for Disease Control and Prevention (CDC). Chlamydia trachomatis genital infections--United States, 1995. MMWR Morb Mortal Wkly Rep. 1997 Mar 7;46(9):193-8.
- Background: PubMed 16210104Darville T. Chlamydia trachomatis infections in neonates and young children. Semin Pediatr Infect Dis. 2005 Oct;16(4):235-44. doi: 10.1053/j.spid.2005.06.004.
- Arkansas Children's Hospital Main PageLink provided by the sponsor.
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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.
Amy M Scurlock, M.D. principal investigator
Arkansas Children's Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CHLAMYDIA INFECTIONS, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
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 8 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 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluate the environmental and behavioral risk factors that predispose toward adverse reproductive outcomes following C. trachomatis genital tract infection in a high risk adolescent population (time frame: enrollment,3,6,12,24,36 months). 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 NCT00607659, which also lists 6 linked publications.
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 14 Apr 2016; AzTrials last refreshed its copy on 29 Oct 2026.