To Investigate the Characteristics and Prognostic Factors of T. Marneffei Infections and the Causes of MisdiagnosisRAECDPTNCT03819348
Retrospective Analysis of the Epidemiological Change and Determinants of Prognosis of Talaromycosisof Human Immunodeficiency Virus Negative Host in Guangxi
An observational study of To Investigate the Characteristics and Prognostic Factors of T. Marneffei Infections and the Causes of Misdiagnosis and To Study the Recurrence Indicators and Establish a Therapeutic Effect Evaluation System of T. Marneffei Infections, run by Guangxi Medical University at 1 site in China.
Trial summary
Through a multi-center large-sample retrospective study, the epidemiological changes of TSM in Guangxi have been reviewed, its incidence trend was understood to attract the attention of clinicians; the multiple programs of antifungal therapy for HIV-negative host TSM were compared in terms of effect on clinical… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- To Investigate the Characteristics and Prognostic Factors of T. Marneffei Infections and the Causes of Misdiagnosis, To Study the Recurrence Indicators and Establish a Therapeutic Effect Evaluation System of T. Marneffei Infections
- What is being tested?
- the multiple programs of antifungal therapy for HIV-negative host
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2003to 30 Jun 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: We studied the clinical characteristics and prognoses of patients with infections due to Talaromyces marneffei who were admitted to Guangxi Hospital, This province is located in subtropical southern China, where Talaromyces marneffei is endemic.
Who may be able to join
- Eligible patients were HIV-negative adults who had talaromycosis that was confirmed by either microscopy or culture.
Who cannot join
- patients were HIV-infected adults who had talaromycosis that was confirmed by either microscopy or culture.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The First Affiliated Hospital of Guangxi Medical University
Through a multi-center large-sample retrospective study, the epidemiological changes of TSM in Guangxi have been reviewed, its incidence trend was understood to attract the attention of clinicians; the multiple programs of antifungal therapy for HIV-negative host TSM were compared in terms of effect on clinical remission rate, effective rate, recurrence rate, mortality and toxic side effects on HIV-negative host TSM; their prognosis and recurrence indicators were clarified, and a therapeutic effect evaluation system was established, providing a standard treatment and diagnosis scheme for clinical practice; and simultaneously the positive rate of G and GM experiments in respect of TSM, Aspergillus and other fungi was identified to provide TSM with biological diagnostic indicators. Improve the level of understanding and diagnosis and treatment of HIV-negative TSM in the whole area. A comprehensive efficacy evaluation system and standard treatment program was established to provide a basis for standardized treatment of TSM in HIV-negative hosts. The observational indicators included: 2-week all-cause mortality; 24-week all-cause mortality; clinical improvement time; level of decrease of fungus in the blood culture medium two weeks before treatment; recurrence; appearance of adverse drug reaction at the level 3 and above.
- Conditions
- To Investigate the Characteristics and Prognostic Factors of T. Marneffei Infections and the Causes of Misdiagnosis, To Study the Recurrence Indicators and Establish a Therapeutic Effect Evaluation System of T. Marneffei Infections
- Being tested
- the multiple programs of antifungal therapy for HIV-negative host
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the multiple programs of antifungal therapy for HIV-negative hostOther
Also called their prognosis and recurrence
the multiple programs of antifungal therapy for HIV-negative host TSM were compared in terms of effect on clinical remission rate, effective rate, recurrence rate, mortality and toxic side effects on HIV-negative host TSM; their prognosis and recurrence indicators were clarified, and a therapeutic effect evaluation system was established, providing a standard treatment and diagnosis scheme for clinical practice; and simultaneously the positive rate of G and GM experiments in respect of TSM, Aspergillus and other fungi was identified to provide TSM with biological diagnostic indicators.
| Study group | Role | What they receive |
|---|---|---|
| TSM of HIV-negative Host | Eligible patients were HIV-infected adults who had talaromycosis that was confirmed by either microscopy or culture. Receives: Other: the multiple programs of antifungal therapy for HIV-negative host |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical remission rate
Clinical resolution of talaromycosis was defined as a temperature of less than 38°C (100°F) for 3 days, resolution of skin lesions, and sterile blood cultures.
Measured: 7 days
recurrence rate
Relapse of talaromycosis was defined as the recurrence of symptoms and a positive fungal culture from any sterile site that led to reinduction of therapy in patients who had achieved clinical resolution.
Measured: 12 months
mortality at 4 week
all-cause mortality was defined as the absolute risk of death from any cause during the first 2 weeks after randomization.
Measured: 4 weeks
toxic side effects
Side effects were monitored clinically and with the use of hematologic, chemical, and liver-enzyme testing performed at least twice weekly
Measured: 24 weeks
mortality at week 24
The secondary outcome measures were mortality at week 24, the time to clinical resolution of talaromycosis, early fungicidal activity, relapse of talaromycosis, and the incidence of adverse events of grade 3 or higher.
Measured: 24 weeks
Secondary outcomes (2)
G test
positive was defined as >20pg/ml
Measured: 3 days
GM test
positive was defined as >0.5
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start1 Jan 2003
- Primary completion30 Dec 2018
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for To Investigate the Characteristics and Prognostic Factors of T. Marneffei Infections and the Causes of MisdiagnosisStudies 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 only
- Time perspective
- Retrospective
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangxi Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Second Affiliated Hospital of Guangzhou Medical University, The Fourth People's Hospital of Nanning, Guilin Medical College, Nanning Second People's Hospital, People's Hospital of Guangxi Zhuang Autonomous Region
- Responsible party
- Principal investigator, Qiu Ye, Guangxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03819348
- Sponsor's protocol ID
- RA-TSM-HIVN-ECDP
- Acronym
- RAECDPT
- Status last verified
- Jan 2019
- First submitted
- 15 Jan 2019
- Last updated
- 28 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Le T, Kinh NV, Cuc NTK, Tung NLN, Lam NT, Thuy PTT, Cuong DD, Phuc PTH, Vinh VH, Hanh DTH, Tam VV, Thanh NT, Thuy TP, Hang NT, Long HB, Nhan HT, Wertheim HFL, Merson L, Shikuma C, Day JN, Chau NVV, Farrar J, Thwaites G, Wolbers M; IVAP Investigators. A Trial of Itraconazole or Amphotericin B for HIV-Associated Talaromycosis. N Engl J Med. 2017 Jun 15;376(24):2329-2340. doi: 10.1056/NEJMoa1613306.
PubMed 28614691
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The First Affiliated Hospital of Guangxi Medical University
- ClinicalTrials.gov ID
- NCT03819348
- Acronym / sponsor ID
- RAECDPT / RA-TSM-HIVN-ECDP
- Conditions
- To Investigate the Characteristics and Prognostic Factors of T. Marneffei Infections and the Causes of Misdiagnosis, To Study the Recurrence Indicators and Establish a Therapeutic Effect Evaluation System of T. Marneffei Infections
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Guangxi Medical UniversityUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital of Guangzhou Medical University, The Fourth People's Hospital of Nanning, Guilin Medical College, Nanning Second People's Hospital, People's Hospital of Guangxi Zhuang Autonomous Region
- Study start
- 1 Jan 2003 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 28 Jan 2019 (actual)
- 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.
Through a multi-center large-sample retrospective study, the epidemiological changes of TSM in Guangxi have been reviewed, its incidence trend was understood to attract the attention of clinicians; the multiple programs of antifungal therapy for HIV-negative host TSM were compared in terms of effect on clinical remission rate, effective rate, recurrence rate, mortality and toxic side effects on HIV-negative host TSM; their prognosis and recurrence indicators were clarified, and a therapeutic effect evaluation system was established, providing a standard treatment and diagnosis scheme for clinical practice; and simultaneously the positive rate of G and GM experiments in respect of TSM, Aspergillus and other fungi was identified to provide TSM with biological diagnostic indicators. Improve the level of understanding and diagnosis and treatment of HIV-negative TSM in the whole area. A comprehensive efficacy evaluation system and standard treatment program was established to provide a basis for standardized treatment of TSM in HIV-negative hosts. The observational indicators included: 2-week all-cause mortality; 24-week all-cause mortality; clinical improvement time; level of decrease of fungus in the blood culture medium two weeks before treatment; recurrence; appearance of adverse drug reaction at the level 3 and above.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TSM of HIV-negative Host | – | Other: the multiple programs of antifungal therapy for HIV-negative hostEligible patients were HIV-infected adults who had talaromycosis that was confirmed by either microscopy or culture. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We studied the clinical characteristics and prognoses of patients with infections due to Talaromyces marneffei who were admitted to Guangxi Hospital, This province is located in subtropical southern China, where Talaromyces marneffei is endemic.
Key inclusion criteria (1 listed)
- Eligible patients were HIV-negative adults who had talaromycosis that was confirmed by either microscopy or culture.
Key exclusion criteria (1 listed)
- patients were HIV-infected adults who had talaromycosis that was confirmed by either microscopy or culture.
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 |
|---|---|---|
| the multiple programs of antifungal therapy for HIV-negative hostAlso: their prognosis and recurrencethe multiple programs of antifungal therapy for HIV-negative host TSM were compared in terms of effect on clinical remission rate, effective rate, recurrence rate, mortality and toxic side effects on HIV-negative host TSM; their prognosis and recurrence indicators were clarified, and a therapeutic effect evaluation system was established, providing a standard treatment and diagnosis scheme for clinical practice; and simultaneously the positive rate of G and GM experiments in respect of TSM, Aspergillus and other fungi was identified to provide TSM with biological diagnostic indicators. | Other | TSM of HIV-negative Host |
Primary outcome
clinical remission rate
Time frame: 7 days
Clinical resolution of talaromycosis was defined as a temperature of less than 38°C (100°F) for 3 days, resolution of skin lesions, and sterile blood cultures.
recurrence rate
Time frame: 12 months
Relapse of talaromycosis was defined as the recurrence of symptoms and a positive fungal culture from any sterile site that led to reinduction of therapy in patients who had achieved clinical resolution.
mortality at 4 week
Time frame: 4 weeks
all-cause mortality was defined as the absolute risk of death from any cause during the first 2 weeks after randomization.
toxic side effects
Time frame: 24 weeks
Side effects were monitored clinically and with the use of hematologic, chemical, and liver-enzyme testing performed at least twice weekly
mortality at week 24
Time frame: 24 weeks
The secondary outcome measures were mortality at week 24, the time to clinical resolution of talaromycosis, early fungicidal activity, relapse of talaromycosis, and the incidence of adverse events of grade 3 or higher.
2 secondary outcomes
G test
Time frame: 3 days
GM test
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2019.
- Results publication: PubMed 28614691Le T, Kinh NV, Cuc NTK, Tung NLN, Lam NT, Thuy PTT, Cuong DD, Phuc PTH, Vinh VH, Hanh DTH, Tam VV, Thanh NT, Thuy TP, Hang NT, Long HB, Nhan HT, Wertheim HFL, Merson L, Shikuma C, Day JN, Chau NVV, Farrar J, Thwaites G, Wolbers M; IVAP Investigators. A Trial of Itraconazole or Amphotericin B for HIV-Associated Talaromycosis. N Engl J Med. 2017 Jun 15;376(24):2329-2340. doi: 10.1056/NEJMoa1613306.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 To Investigate the Characteristics and Prognostic Factors of T. Marneffei Infections and the Causes of Misdiagnosis and To Study the Recurrence Indicators and Establish a Therapeutic Effect Evaluation System of T. Marneffei Infections, run by Guangxi Medical University at 1 site in China.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 28 Jan 2019. 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 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?
Results are not available in the source record.
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?
clinical remission rate (time frame: 7 days). The study lists 5 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 NCT03819348, which also lists 1 linked publication.
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 28 Jan 2019.