Opportunistic Fungal InfectionsNCT05153005
Comprehensive Diagnosis and Treatment Strategy for Opportunistic Fungal Infections in AIDS Patients
An observational study of Opportunistic Fungal Infections, run by Guangzhou 8th People's Hospital at 1 site in China.
Trial summary
Opportunistic fungal infection is the most common opportunistic infection in AIDS patients, with the high mortality and recurrence rate due to the lack of standardized comprehensive diagnosis and treatment strategy. Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Opportunistic Fungal Infections
- What is being tested?
- examination methods
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2021to 31 Dec 2023
- 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 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Population for screening of important opportunistic fungal infections: About 2000 AIDS patients, with CD4 + < 200 cells /μ, regardless of whether they received ART or not. Population for efficacy evaluation: about 420 patients with AIDS complicated with Talaromycosis, PCP or cryptococcosis.
Who may be able to join
- Age (16-70 years), male and female;
- HIV-1 infected;
- hospitalized patients with the signs or symptoms inferred to infection;
- Initial CD4 cell count less than 200 cells/ul; HIV-1 RNA viral load was unlimited;
- State Informed Consent for Free Treatment has been signed;
- Good compliance and signing Informed Consent
Who cannot join
- have been treated regularly in other hospitals or have been clearly diagnosed before admission;
- Researchers decide if patients could/not complete the scheduled follow-up (factors to consider such as weak, poor compliance, etc.);
- Pregnancy during the study period;
- Hospital stay less than 7 days.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangzhou Eighth People's Hospital, Guangzhou Medical University
Guangzhou, Guangdong, 510060
Linghua Li, PhD, +862083710825, llheliza@126.com
Pengle Guo, Master, +862083710825, lelegpl@qq.com
About this study
Opportunistic fungal infection is the most common opportunistic infection in AIDS patients, with the high mortality and recurrence rate due to the lack of standardized comprehensive diagnosis and treatment strategy. This project aims to combine traditional detection and observation indicators with molecular biology, serology and mass spectrometry identification technology to develop early screening and diagnostic strategies for opportunistic fungal infections in AIDS patients, explore scientific evaluation methods for anti-fungal efficacy and formulate comprehensive strategies for reducing the mortality and recurrence rate.
Read the detailed description
The research involves AIDS patients complicated with talaromycosis, PCP and cryptococcosis in the study.
The main contents:
- To explore early screening and diagnostic strategies. To advance the application of taloromyces marneffeispecific mannose protein (Mp1p), (1,3)- β- D-glucan (G antigen) and Cryptococcus capsular antigen (CrAg) serological detection, qPCR, dd- PCR and mass spectrometry identification In clinical practice.
- To develop scientific evaluation strategy of anti-fungal treatment effect. On the basis of routine clinical, laboratory, imaging indexes and QFC, qPCR, dd-PCR and serological quantitative detection methods were combined to explore strategies for evaluating anti-fungal efficacy. 3 .To determine the termination timing of secondary prevention To explore the scientific timing to terminate secondary prevention after ART, Combing CD4 + T cell count with plasma HIV RNA, HIV DNA of peripheral blood mononuclear cells (PBMC), CD4 + / CD8+ ratio and chronic immune activation index
- Conditions
- Opportunistic Fungal Infections
- Being tested
- examination methods
- Keywords
- Talaromycosis, Pneumocystis pneumonia, Cryptococcus Infection
- Medical subject headings
- talaromycosis, Pneumonia, Pneumocystis, Cryptococcosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
examination methodsOther
Some advanced methods: mannose protein (Mp1p), (1,3)- β- D-glucan (G antigen) and Cryptococcus capsular antigen (CrAg) serological detection, qPCR, dd- PCR and mass spectrometry identification, QFC.
| Study group | Role | What they receive |
|---|---|---|
| Talaromycosis | Participants: AIDS patients complicated with Talaromycosis. Intervention(s): To use the specific antigen of taloromyces marneffei which is mannose protein (Mp1p), (1,3)- β- D-glucan (G antigen) and qPCR, dd-PCR and mass spectrometry identification in the diagnosis and efficacy evaluation of AIDS patients complicated with Talaromycosis. Receives: Other: examination methods | |
| Pneumocystis pneumonia | Participants: AIDS patients complicated with Pneumocystis pneumonia Intervention(s)：To use (1,3)- β- D-glucan (G antigen) , qPCR, dd-PCR and mass spectrometry identification, to explore the methods of screening and early diagnosis strategies. Receives: Other: examination methods | |
| Cryptococcus | Participants: AIDS patients complicated with Cryptococcus Intervention(s)：To use (1,3)- β- D-glucan (G antigen) and Cryptococcus capsular antigen(CrAg) serological detection, qPCR, DD PCR and mass spectrometry identification, to explore the methods of screening and early diagnosis strategies of disease. Receives: Other: examination methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients who achieved etiological diagnosis of opportunistic fungal infection
The probability of etiological diagnosis achieved by new diagnostic techniques after admission
Measured: 2 weeks
Number of hospitalized patients who achieved clinical remission or cure
The improvement of treatment efficiency for treating with 3 main opportunistic fungal infections in AIDS patients when applying with new diagnostic techniques
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start1 Apr 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Opportunistic Fungal 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou 8th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linghua LI, Guangzhou 8th People's Hospital
- Investigators
- Ruosu Ying, PhD, Study director, Guangzhou Eighth People's Hospital, Guangzhou Medical University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05153005
- Sponsor's protocol ID
- 202034167
- Status last verified
- Dec 2021
- First submitted
- 15 Nov 2021
- Last updated
- 13 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
IeDEA and ART Cohort Collaborations; Avila D, Althoff KN, Mugglin C, Wools-Kaloustian K, Koller M, Dabis F, Nash D, Gsponer T, Sungkanuparph S, McGowan C, May M, Cooper D, Chimbetete C, Wolff M, Collier A, McManus H, Davies MA, Costagliola D, Crabtree-Ramirez B, Chaiwarith R, Cescon A, Cornell M, Diero L, Phanuphak P, Sawadogo A, Ehmer J, Eholie SP, Li PC, Fox MP, Gandhi NR, Gonzalez E, Lee CK, Hoffmann CJ, Kambugu A, Keiser O, Ditangco R, Prozesky H, Lampe F, Kumarasamy N, Kitahata M, Lugina E, Lyamuya R, Vonthanak S, Fink V, d'Arminio Monforte A, Luz PM, Chen YM, Minga A, Casabona J, Mwango A, Choi JY, Newell ML, Bukusi EA, Ngonyani K, Merati TP, Otieno J, Bosco MB, Phiri S, Ng OT, Anastos K, Rockstroh J, Santos I, Oka S, Somi G, Stephan C, Teira R, Wabwire D, Wandeler G, Boulle A, Reiss P, Wood R, Chi BH, Williams C, Sterne JA, Egger M. Immunodeficiency at the start of combination antiretroviral therapy in low-, middle-, and high-income countries. J Acquir Immune Defic Syndr. 2014 Jan 1;65(1):e8-16. doi: 10.1097/QAI.0b013e3182a39979.
PubMed 24419071Waldrop G, Doherty M, Vitoria M, Ford N. Stable patients and patients with advanced disease: consensus definitions to support sustained scale up of antiretroviral therapy. Trop Med Int Health. 2016 Sep;21(9):1124-30. doi: 10.1111/tmi.12746. Epub 2016 Jul 22.
PubMed 27371814Tanuma J, Lee KH, Haneuse S, Matsumoto S, Nguyen DT, Nguyen DT, Do CD, Pham TT, Nguyen KV, Oka S. Incidence of AIDS-Defining Opportunistic Infections and Mortality during Antiretroviral Therapy in a Cohort of Adult HIV-Infected Individuals in Hanoi, 2007-2014. PLoS One. 2016 Mar 3;11(3):e0150781. doi: 10.1371/journal.pone.0150781. eCollection 2016.
PubMed 26939050Luo B, Sun J, Cai R, Shen Y, Liu L, Wang J, Zhang R, Shen J, Lu H. Spectrum of Opportunistic Infections and Risk Factors for In-Hospital Mortality of Admitted AIDS Patients in Shanghai. Medicine (Baltimore). 2016 May;95(21):e3802. doi: 10.1097/MD.0000000000003802.
PubMed 27227959Limper AH, Adenis A, Le T, Harrison TS. Fungal infections in HIV/AIDS. Lancet Infect Dis. 2017 Nov;17(11):e334-e343. doi: 10.1016/S1473-3099(17)30303-1. Epub 2017 Jul 31.
PubMed 28774701Jarvis JN, Govender N, Chiller T, Park BJ, Longley N, Meintjes G, Bekker LG, Wood R, Lawn SD, Harrison TS. Cryptococcal antigen screening and preemptive therapy in patients initiating antiretroviral therapy in resource-limited settings: a proposed algorithm for clinical implementation. J Int Assoc Physicians AIDS Care (Chic). 2012 Nov-Dec;11(6):374-9. doi: 10.1177/1545109712459077. Epub 2012 Sep 26.
PubMed 23015379Beyene T, Zewde AG, Balcha A, Hirpo B, Yitbarik T, Gebissa T, Rajasingham R, Boulware DR. Inadequacy of High-Dose Fluconazole Monotherapy Among Cerebrospinal Fluid Cryptococcal Antigen (CrAg)-Positive Human Immunodeficiency Virus-Infected Persons in an Ethiopian CrAg Screening Program. Clin Infect Dis. 2017 Nov 29;65(12):2126-2129. doi: 10.1093/cid/cix613.
PubMed 29020172Kim YJ, Woo JH, Kim MJ, Park DW, Song JY, Kim SW, Choi JY, Kim JM, Han SH, Lee JS, Choi BY, Lee JS, Kim SS, Kee MK, Kang MW, Kim SI. Opportunistic diseases among HIV-infected patients: a multicenter-nationwide Korean HIV/AIDS cohort study, 2006 to 2013. Korean J Intern Med. 2016 Sep;31(5):953-60. doi: 10.3904/kjim.2014.322. Epub 2016 Apr 27.
PubMed 27117317Pruksaphon K, Intaramat A, Ratanabanangkoon K, Nosanchuk JD, Vanittanakom N, Youngchim S. Development and characterization of an immunochromatographic test for the rapid diagnosis of Talaromyces (Penicillium) marneffei. PLoS One. 2018 Apr 11;13(4):e0195596. doi: 10.1371/journal.pone.0195596. eCollection 2018.
PubMed 29641620Song Y, Ren Y, Wang X, Li R. Recent Advances in the Diagnosis of Pneumocystis Pneumonia. Med Mycol J. 2016;57(4):E111-E116. doi: 10.3314/mmj.16-00019.
PubMed 27904052
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Diagnosis and Treatment Strategy for Opportunistic Fungal Infections in AIDS Patients
- ClinicalTrials.gov ID
- NCT05153005
- Acronym / sponsor ID
- 202034167
- Conditions
- Opportunistic Fungal Infections
- Keywords
- Talaromycosis, Pneumocystis pneumonia, Cryptococcus Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Guangzhou 8th People's HospitalUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 10 Dec 2021 (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.
Opportunistic fungal infection is the most common opportunistic infection in AIDS patients, with the high mortality and recurrence rate due to the lack of standardized comprehensive diagnosis and treatment strategy. This project aims to combine traditional detection and observation indicators with molecular biology, serology and mass spectrometry identification technology to develop early screening and diagnostic strategies for opportunistic fungal infections in AIDS patients, explore scientific evaluation methods for anti-fungal efficacy and formulate comprehensive strategies for reducing the mortality and recurrence rate.
Detailed description
The research involves AIDS patients complicated with talaromycosis, PCP and cryptococcosis in the study.
The main contents:
- To explore early screening and diagnostic strategies. To advance the application of taloromyces marneffeispecific mannose protein (Mp1p), (1,3)- β- D-glucan (G antigen) and Cryptococcus capsular antigen (CrAg) serological detection, qPCR, dd- PCR and mass spectrometry identification In clinical practice.
- To develop scientific evaluation strategy of anti-fungal treatment effect. On the basis of routine clinical, laboratory, imaging indexes and QFC, qPCR, dd-PCR and serological quantitative detection methods were combined to explore strategies for evaluating anti-fungal efficacy. 3 .To determine the termination timing of secondary prevention To explore the scientific timing to terminate secondary prevention after ART, Combing CD4 + T cell count with plasma HIV RNA, HIV DNA of peripheral blood mononuclear cells (PBMC), CD4 + / CD8+ ratio and chronic immune activation index
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Talaromycosis | – | Other: examination methodsParticipants: AIDS patients complicated with Talaromycosis. Intervention(s): To use the specific antigen of taloromyces marneffei which is mannose protein (Mp1p), (1,3)- β- D-glucan (G antigen) and qPCR, dd-PCR and mass spectrometry identification in the diagnosis and efficacy evaluation of AIDS patients complicated with Talaromycosis. |
| Pneumocystis pneumonia | – | Other: examination methodsParticipants: AIDS patients complicated with Pneumocystis pneumonia Intervention(s)：To use (1,3)- β- D-glucan (G antigen) , qPCR, dd-PCR and mass spectrometry identification, to explore the methods of screening and early diagnosis strategies. |
| Cryptococcus | – | Other: examination methodsParticipants: AIDS patients complicated with Cryptococcus Intervention(s)：To use (1,3)- β- D-glucan (G antigen) and Cryptococcus capsular antigen(CrAg) serological detection, qPCR, DD PCR and mass spectrometry identification, to explore the methods of screening and early diagnosis strategies of disease. |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Population for screening of important opportunistic fungal infections: About 2000 AIDS patients, with CD4 + < 200 cells /μ, regardless of whether they received ART or not. Population for efficacy evaluation: about 420 patients with AIDS complicated with Talaromycosis, PCP or cryptococcosis.
Key inclusion criteria (6 listed)
- Age (16-70 years), male and female;
- HIV-1 infected;
- hospitalized patients with the signs or symptoms inferred to infection;
- Initial CD4 cell count less than 200 cells/ul; HIV-1 RNA viral load was unlimited;
- State Informed Consent for Free Treatment has been signed;
Key exclusion criteria (4 listed)
- have been treated regularly in other hospitals or have been clearly diagnosed before admission;
- Researchers decide if patients could/not complete the scheduled follow-up (factors to consider such as weak, poor compliance, etc.);
- Pregnancy during the study period;
- Hospital stay less than 7 days.
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 |
|---|---|---|
| examination methodsSome advanced methods: mannose protein (Mp1p), (1,3)- β- D-glucan (G antigen) and Cryptococcus capsular antigen (CrAg) serological detection, qPCR, dd- PCR and mass spectrometry identification, QFC. | Other | Cryptococcus, Pneumocystis pneumonia, Talaromycosis |
Primary outcome
The number of patients who achieved etiological diagnosis of opportunistic fungal infection
Time frame: 2 weeks
The probability of etiological diagnosis achieved by new diagnostic techniques after admission
Number of hospitalized patients who achieved clinical remission or cure
Time frame: 6 months
The improvement of treatment efficiency for treating with 3 main opportunistic fungal infections in AIDS patients when applying with new diagnostic techniques
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2021.
- Background: PubMed 24419071IeDEA and ART Cohort Collaborations; Avila D, Althoff KN, Mugglin C, Wools-Kaloustian K, Koller M, Dabis F, Nash D, Gsponer T, Sungkanuparph S, McGowan C, May M, Cooper D, Chimbetete C, Wolff M, Collier A, McManus H, Davies MA, Costagliola D, Crabtree-Ramirez B, Chaiwarith R, Cescon A, Cornell M, Diero L, Phanuphak P, Sawadogo A, Ehmer J, Eholie SP, Li PC, Fox MP, Gandhi NR, Gonzalez E, Lee CK, Hoffmann CJ, Kambugu A, Keiser O, Ditangco R, Prozesky H, Lampe F, Kumarasamy N, Kitahata M, Lugina E, Lyamuya R, Vonthanak S, Fink V, d'Arminio Monforte A, Luz PM, Chen YM, Minga A, Casabona J, Mwango A, Choi JY, Newell ML, Bukusi EA, Ngonyani K, Merati TP, Otieno J, Bosco MB, Phiri S, Ng OT, Anastos K, Rockstroh J, Santos I, Oka S, Somi G, Stephan C, Teira R, Wabwire D, Wandeler G, Boulle A, Reiss P, Wood R, Chi BH, Williams C, Sterne JA, Egger M. Immunodeficiency at the start of combination antiretroviral therapy in low-, middle-, and high-income countries. J Acquir Immune Defic Syndr. 2014 Jan 1;65(1):e8-16. doi: 10.1097/QAI.0b013e3182a39979.
- Background: PubMed 27371814Waldrop G, Doherty M, Vitoria M, Ford N. Stable patients and patients with advanced disease: consensus definitions to support sustained scale up of antiretroviral therapy. Trop Med Int Health. 2016 Sep;21(9):1124-30. doi: 10.1111/tmi.12746. Epub 2016 Jul 22.
- Background: PubMed 26939050Tanuma J, Lee KH, Haneuse S, Matsumoto S, Nguyen DT, Nguyen DT, Do CD, Pham TT, Nguyen KV, Oka S. Incidence of AIDS-Defining Opportunistic Infections and Mortality during Antiretroviral Therapy in a Cohort of Adult HIV-Infected Individuals in Hanoi, 2007-2014. PLoS One. 2016 Mar 3;11(3):e0150781. doi: 10.1371/journal.pone.0150781. eCollection 2016.
- Background: PubMed 27227959Luo B, Sun J, Cai R, Shen Y, Liu L, Wang J, Zhang R, Shen J, Lu H. Spectrum of Opportunistic Infections and Risk Factors for In-Hospital Mortality of Admitted AIDS Patients in Shanghai. Medicine (Baltimore). 2016 May;95(21):e3802. doi: 10.1097/MD.0000000000003802.
- Background: PubMed 28774701Limper AH, Adenis A, Le T, Harrison TS. Fungal infections in HIV/AIDS. Lancet Infect Dis. 2017 Nov;17(11):e334-e343. doi: 10.1016/S1473-3099(17)30303-1. Epub 2017 Jul 31.
- Background: PubMed 23015379Jarvis JN, Govender N, Chiller T, Park BJ, Longley N, Meintjes G, Bekker LG, Wood R, Lawn SD, Harrison TS. Cryptococcal antigen screening and preemptive therapy in patients initiating antiretroviral therapy in resource-limited settings: a proposed algorithm for clinical implementation. J Int Assoc Physicians AIDS Care (Chic). 2012 Nov-Dec;11(6):374-9. doi: 10.1177/1545109712459077. Epub 2012 Sep 26.
- Background: PubMed 29020172Beyene T, Zewde AG, Balcha A, Hirpo B, Yitbarik T, Gebissa T, Rajasingham R, Boulware DR. Inadequacy of High-Dose Fluconazole Monotherapy Among Cerebrospinal Fluid Cryptococcal Antigen (CrAg)-Positive Human Immunodeficiency Virus-Infected Persons in an Ethiopian CrAg Screening Program. Clin Infect Dis. 2017 Nov 29;65(12):2126-2129. doi: 10.1093/cid/cix613.
- Background: PubMed 27117317Kim YJ, Woo JH, Kim MJ, Park DW, Song JY, Kim SW, Choi JY, Kim JM, Han SH, Lee JS, Choi BY, Lee JS, Kim SS, Kee MK, Kang MW, Kim SI. Opportunistic diseases among HIV-infected patients: a multicenter-nationwide Korean HIV/AIDS cohort study, 2006 to 2013. Korean J Intern Med. 2016 Sep;31(5):953-60. doi: 10.3904/kjim.2014.322. Epub 2016 Apr 27.
- Background: PubMed 29641620Pruksaphon K, Intaramat A, Ratanabanangkoon K, Nosanchuk JD, Vanittanakom N, Youngchim S. Development and characterization of an immunochromatographic test for the rapid diagnosis of Talaromyces (Penicillium) marneffei. PLoS One. 2018 Apr 11;13(4):e0195596. doi: 10.1371/journal.pone.0195596. eCollection 2018.
- Background: PubMed 27904052Song Y, Ren Y, Wang X, Li R. Recent Advances in the Diagnosis of Pneumocystis Pneumonia. Med Mycol J. 2016;57(4):E111-E116. doi: 10.3314/mmj.16-00019.
- Individual participant dataSharing planned: No
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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.
Ruosu Ying, PhD study director
Guangzhou Eighth People's Hospital, Guangzhou Medical University.
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 Opportunistic Fungal Infections, run by Guangzhou 8th People's Hospital 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 6 inclusion and 4 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 13 Dec 2021. 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?
Contact Linghua Li, PhD (02083710825, llheliza@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of patients who achieved etiological diagnosis of opportunistic fungal infection (time frame: 2 weeks). The study lists 2 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 NCT05153005, which also lists 10 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 13 Dec 2021.