TetanusPhase 1/2ITITTTNCT02999815
Intrathecal Tetanus Immunoglobulin to Treat Tetanus
A Phase 1/2 study testing Human tetanus immunoglobulin and Intramuscular antitoxin in people with Tetanus, run by Oxford University Clinical Research Unit, Vietnam at 1 site in Vietnam.
Trial summary
To establish whether the addition of intrathecal tetanus antitoxin reduces the need for mechanical ventilation in patients with tetanus Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Tetanus
- What is being tested?
- Human tetanus immunoglobulin and Intramuscular antitoxin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 272 participants
- Where
- 1 siteVietnam
- Study dates
- 13 Feb 2017to 1 May 2020
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All adult patients (≥16 years old) with a clinical diagnosis of generalized tetanus admitted to the intensive care unit (ICU) at the Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
Who cannot join
- Prior administration of antitoxin during this episode
- Contra-indication to use of human or equine antitoxin
- Contra-indication to lumbar puncture
- Already receiving mechanical ventilation or expected to require this before intrathecal injection can be given
- Pregnancy
- Informed consent not obtained
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intrathecal Immunoglobulin for Treatment of Adult Patients With Tetanus: a Randomized Controlled 2x2 Factorial Trial
To establish whether the addition of intrathecal tetanus antitoxin reduces the need for mechanical ventilation in patients with tetanus
Read the detailed description
The investigators will conduct a randomised partially-blinded controlled 2x2 factorial trial. First, adults admitted to the Intensive Care Unit at the Hospital for Tropical Diseases Ho Chi Minh City will be randomized to receive either human (3000 IU) or equine (21,000 units) intramuscular antitoxin. Second, participants will be randomized to receive either standard treatment with intramuscular antitoxin alone or with the addition of 500 IU intrathecal human antitoxin. Patients with prior antitoxin treatment and those with contra-indications to lumbar puncture or antitoxin treatment will be excluded.
All patients will receive other standard tetanus treatment as deemed necessary by the attending physicians. Spasms will be treated with benzodiazepines as first-line therapy. Patients with spasms not controlled with benzodiazepines will receive tracheostomy, paralysis, magnesium sulphate and mechanical ventilation. Heart rate, BP, temperature and daily drug use will be recorded throughout the ICU stay. Patients will be followed following discharge from hospital until 240 days for disability/ death.
- Conditions
- Tetanus
- Being tested
- Human tetanus immunoglobulin, Intramuscular antitoxin
- Keywords
- Tetanus
- Medical subject headings
- Tetanus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human tetanus immunoglobulinProcedure or surgery
Also called Human tetanus immunoglobulin (Tetagam-P)
Adults admitted to ICU at Hospital for Tropical Diseases will be randomized to receive either human (3000 IU) or equine (21,000 units) intramuscular antitoxin. Second, participants will be randomized to receive the addition of 500 IU intrathecal human antitoxin.
Intramuscular antitoxinProcedure or surgery
First, adults admitted to ICU at Hospital for Tropical Diseases will be randomized to receive either human (3000 IU) or equine (21,000 units) intramuscular antitoxin including a 0.05ml test dose (ie 75 units equine antitoxin or 12.5 IU human antitoxin). Second, participants will be randomized with sham procedure
| Study group | Role | What they receive |
|---|---|---|
| Human tetanus immunoglobulin | Active comparator | Human tetanus immunoglobulin (Tetagam-P): Injection (prefilled syringe) 250 IU in 1 ml - Intrathecal 500 IU Receives: Procedure: Human tetanus immunoglobulin |
| Intramuscular antitoxin | Sham comparator | Human tetanus immunoglobulin (Tetagam-P): Injection (prefilled syringe) 250 IU in 1 ml - Intramuscular 3000 IU OR Equine antiserum - 21,000 units Receives: Procedure: Human tetanus immunoglobulin; Procedure: Intramuscular antitoxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Requirement for mechanical ventilation during ICU stay
Criteria for mechanical ventilation are oxygen saturation (SpO2) <90%; or partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) <250; or excessive spasms necessitating muscle paralysis.
These criteria are intended as a guide and the final decision to ventilate a patient rests with the individual doctor responsible for the patient.
Measured: During ICU stay, an average of 3 weeks
Secondary outcomes (10)
Duration of ICU stay
Measured: During ICU stay, an average of 3 weeks
Duration of hospital stay
Measured: During hospital stay, an average of 5 weeks
Duration of mechanical ventilation
Measured: During hospital stay, an average of 5 weeks
In hospital and 240 day mortality
Measured: 240 days
In hospital and 240 day disability
Measured: 240 days
New antibiotic prescription during ICU stay
New antibiotic prescription during ICU stay (excluding antibiotics for tetanus or initial entry site infection)
Measured: During ICU stay, an average of 3 weeks
Incidence of Ventilator Associated Pneumonia
Definition of Ventilator associated pneumonia (VAP):
Mechanical ventilation for at least 48 hours and with the tube in place within the last 48 hours and 2 of:
- Temperature > 38°C or < 36°C
- White blood cell count <4.0 x 109/L or ≥12 x 109/L
- Purulent respiratory secretions
- New or progressive changes on chest radiography (for VAP) Plus for microbiologically confirmed VAP
- Bacterial growth of ≥105 cfu/ml from endotracheal aspirate (ETA) (or ≥104 cfu/ml from Broncho Alveolar Lavage (BAL))
Measured: During hospital stay, an average of 5 weeks
Incidence of clinical syndrome of autonomic nervous system dysfunction
At least 3 of the following criteria:
- Tachycardia Heart Rate (HR)> 100 bpm
- Hypertension Systolic Blood Pressure (SBP) > 140 mmHg
- Hypotension Mean Arterial Pressure (MAP) < 60 mmHg
- Pyrexia > 38°C
- Alteration between hypertension and hypotension
Measured: 240 days
Total dose of benzodiazepines and pipecuronium during hospital stay
Measured: During hospital stay, an average of 5 weeks
Incidence of adverse events
Measured: During hospital stay, an average of 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study start13 Feb 2017
- Primary completion31 Dec 2019
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (57)Papers the sponsor has linked to this study.
- Other trials for TetanusStudies 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Clinical Research Unit, Vietnam
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
- Responsible party
- Sponsor
- Investigators
- Minh Yen Lam, MD, Principal investigator, Oxford University Clinical Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02999815
- Sponsor's protocol ID
- 03TS
- Acronym
- ITITTT
- Status last verified
- May 2020
- First submitted
- 14 Dec 2016
- Last updated
- 29 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jiang D, Pu X, Wu J, Li M, Liu P. Rapid, sensitive, and specific detection of Clostridium tetani by loop-mediated isothermal amplification assay. J Microbiol Biotechnol. 2013 Jan;23(1):1-6. doi: 10.4014/jmb.1205.05063.
PubMed 23314360Thwaites CL, Yen LM, Nga NT, Parry J, Binh NT, Loan HT, Thuy TT, Bethell D, Parry CM, White NJ, Day NP, Farrar JJ. Impact of improved vaccination programme and intensive care facilities on incidence and outcome of tetanus in southern Vietnam, 1993-2002. Trans R Soc Trop Med Hyg. 2004 Nov;98(11):671-7. doi: 10.1016/j.trstmh.2004.01.008.
PubMed 15363647Rosenthal VD, Maki DG, Salomao R, Moreno CA, Mehta Y, Higuera F, Cuellar LE, Arikan OA, Abouqal R, Leblebicioglu H; International Nosocomial Infection Control Consortium. Device-associated nosocomial infections in 55 intensive care units of 8 developing countries. Ann Intern Med. 2006 Oct 17;145(8):582-91. doi: 10.7326/0003-4819-145-8-200610170-00007.
PubMed 17043340Thwaites CL, Yen LM, Loan HT, Thuy TT, Thwaites GE, Stepniewska K, Soni N, White NJ, Farrar JJ. Magnesium sulphate for treatment of severe tetanus: a randomised controlled trial. Lancet. 2006 Oct 21;368(9545):1436-43. doi: 10.1016/S0140-6736(06)69444-0.
PubMed 17055945Ildirim I. A new treatment for neonatal tetanus. Antitetanic serum and prednisolone given together intrathecally. Turk J Pediatr. 1967 Jul;9(3):89-95. No abstract available.
PubMed 5630851St-Amour I, Pare I, Alata W, Coulombe K, Ringuette-Goulet C, Drouin-Ouellet J, Vandal M, Soulet D, Bazin R, Calon F. Brain bioavailability of human intravenous immunoglobulin and its transport through the murine blood-brain barrier. J Cereb Blood Flow Metab. 2013 Dec;33(12):1983-92. doi: 10.1038/jcbfm.2013.160. Epub 2013 Sep 18.
PubMed 24045402Miana-Mena FJ, Roux S, Benichou JC, Osta R, Brulet P. Neuronal activity-dependent membrane traffic at the neuromuscular junction. Proc Natl Acad Sci U S A. 2002 Mar 5;99(5):3234-9. doi: 10.1073/pnas.052023599.
PubMed 11880654Sancho A, Melchiorri D, Abadie E; Committee for Medicinal Products for Human Use, European Medicines Agency. More on influenza vaccine in young children. N Engl J Med. 2012 Jun 28;366(26):2528; author reply 2528-9. doi: 10.1056/NEJMc1205643. No abstract available.
PubMed 22738111Lalli G, Schiavo G. Analysis of retrograde transport in motor neurons reveals common endocytic carriers for tetanus toxin and neurotrophin receptor p75NTR. J Cell Biol. 2002 Jan 21;156(2):233-9. doi: 10.1083/jcb.200106142. Epub 2002 Jan 21.
PubMed 11807088FRIEDEMANN U, TRAUB FB. Pathogenesis of local tetanus in the dog and the cat. J Immunol. 1949 Sep;63(1):23-8. No abstract available.
PubMed 18139406Roux E, Borrel A. Tetanos Cerebral et immunite contre le tetanus. Ann Inst Pasteur (Paris) [Internet]. 1898;12(4):525-35. Available from: https://archive.org/stream/annalesdelinstit12inst
Florey H, Fildes P. Tetanus . -Vii . the Treatment of Tetanus in Rabbits By Large Intrathecal Doses of Antitoxin . Br J Exp Pathol. 1927;(October):393-7
Sherrington BYCS. The serum treatment of experimental tetanus in monkeys. Lancet. 1917;964:54-68
Sedaghatian MR. Intrathecal serotherapy in neonatal tetanus: a controlled trial. Arch Dis Child. 1979 Aug;54(8):623-5. doi: 10.1136/adc.54.8.623.
PubMed 389175Ildirim I. Intrathecal serotherapy of tetanus. I. Explanation of complications. II. Comparison of intrathecal tetanus immune globulin and tetanus antitoxin. Turk J Pediatr. 1974 Jul;16(3):103-10. No abstract available.
PubMed 4480716
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrathecal Immunoglobulin for Treatment of Adult Patients With Tetanus: a Randomized Controlled 2x2 Factorial Trial
- ClinicalTrials.gov ID
- NCT02999815
- Acronym / sponsor ID
- ITITTT / 03TS
- Conditions
- Tetanus
- Keywords
- Tetanus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Oxford University Clinical Research Unit, VietnamUniversity, hospital or other
- Collaborators
- Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
- Study start
- 13 Feb 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 21 Dec 2016 (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.
To establish whether the addition of intrathecal tetanus antitoxin reduces the need for mechanical ventilation in patients with tetanus
Detailed description
The investigators will conduct a randomised partially-blinded controlled 2x2 factorial trial. First, adults admitted to the Intensive Care Unit at the Hospital for Tropical Diseases Ho Chi Minh City will be randomized to receive either human (3000 IU) or equine (21,000 units) intramuscular antitoxin. Second, participants will be randomized to receive either standard treatment with intramuscular antitoxin alone or with the addition of 500 IU intrathecal human antitoxin. Patients with prior antitoxin treatment and those with contra-indications to lumbar puncture or antitoxin treatment will be excluded.
All patients will receive other standard tetanus treatment as deemed necessary by the attending physicians. Spasms will be treated with benzodiazepines as first-line therapy. Patients with spasms not controlled with benzodiazepines will receive tracheostomy, paralysis, magnesium sulphate and mechanical ventilation. Heart rate, BP, temperature and daily drug use will be recorded throughout the ICU stay. Patients will be followed following discharge from hospital until 240 days for disability/ death.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Human tetanus immunoglobulin | Active comparator | Procedure: Human tetanus immunoglobulinHuman tetanus immunoglobulin (Tetagam-P): Injection (prefilled syringe) 250 IU in 1 ml - Intrathecal 500 IU |
| Intramuscular antitoxin | Sham comparator | Procedure: Human tetanus immunoglobulin, Procedure: Intramuscular antitoxinHuman tetanus immunoglobulin (Tetagam-P): Injection (prefilled syringe) 250 IU in 1 ml - Intramuscular 3000 IU OR Equine antiserum - 21,000 units |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients (≥16 years old) with a clinical diagnosis of generalized tetanus admitted to the intensive care unit (ICU) at the Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
Key exclusion criteria (6 listed)
- Prior administration of antitoxin during this episode
- Contra-indication to use of human or equine antitoxin
- Contra-indication to lumbar puncture
- Already receiving mechanical ventilation or expected to require this before intrathecal injection can be given
- Pregnancy
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 |
|---|---|---|
| Human tetanus immunoglobulinAlso: Human tetanus immunoglobulin (Tetagam-P)Adults admitted to ICU at Hospital for Tropical Diseases will be randomized to receive either human (3000 IU) or equine (21,000 units) intramuscular antitoxin. Second, participants will be randomized to receive the addition of 500 IU intrathecal human antitoxin. | Procedure or surgery | Human tetanus immunoglobulin, Intramuscular antitoxin |
| Intramuscular antitoxinFirst, adults admitted to ICU at Hospital for Tropical Diseases will be randomized to receive either human (3000 IU) or equine (21,000 units) intramuscular antitoxin including a 0.05ml test dose (ie 75 units equine antitoxin or 12.5 IU human antitoxin). Second, participants will be randomized with sham procedure | Procedure or surgery | Intramuscular antitoxin |
Primary outcome
Requirement for mechanical ventilation during ICU stay
Time frame: During ICU stay, an average of 3 weeks
Criteria for mechanical ventilation are oxygen saturation (SpO2) <90%; or partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) <250; or excessive spasms necessitating muscle paralysis. These criteria are intended as a guide and the final decision to ventilate a patient rests with the individual doctor responsible for the patient.
10 secondary outcomes
Duration of ICU stay
Time frame: During ICU stay, an average of 3 weeks
Duration of hospital stay
Time frame: During hospital stay, an average of 5 weeks
Duration of mechanical ventilation
Time frame: During hospital stay, an average of 5 weeks
In hospital and 240 day mortality
Time frame: 240 days
In hospital and 240 day disability
Time frame: 240 days
New antibiotic prescription during ICU stay
Time frame: During ICU stay, an average of 3 weeks
Incidence of Ventilator Associated Pneumonia
Time frame: During hospital stay, an average of 5 weeks
Incidence of clinical syndrome of autonomic nervous system dysfunction
Time frame: 240 days
Total dose of benzodiazepines and pipecuronium during hospital stay
Time frame: During hospital stay, an average of 5 weeks
Incidence of adverse events
Time frame: During hospital stay, an average of 5 weeks
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 29 May 2020.
- Background: PubMed 23314360Jiang D, Pu X, Wu J, Li M, Liu P. Rapid, sensitive, and specific detection of Clostridium tetani by loop-mediated isothermal amplification assay. J Microbiol Biotechnol. 2013 Jan;23(1):1-6. doi: 10.4014/jmb.1205.05063.
- Background: PubMed 15363647Thwaites CL, Yen LM, Nga NT, Parry J, Binh NT, Loan HT, Thuy TT, Bethell D, Parry CM, White NJ, Day NP, Farrar JJ. Impact of improved vaccination programme and intensive care facilities on incidence and outcome of tetanus in southern Vietnam, 1993-2002. Trans R Soc Trop Med Hyg. 2004 Nov;98(11):671-7. doi: 10.1016/j.trstmh.2004.01.008.
- Background: PubMed 17043340Rosenthal VD, Maki DG, Salomao R, Moreno CA, Mehta Y, Higuera F, Cuellar LE, Arikan OA, Abouqal R, Leblebicioglu H; International Nosocomial Infection Control Consortium. Device-associated nosocomial infections in 55 intensive care units of 8 developing countries. Ann Intern Med. 2006 Oct 17;145(8):582-91. doi: 10.7326/0003-4819-145-8-200610170-00007.
- Background: PubMed 17055945Thwaites CL, Yen LM, Loan HT, Thuy TT, Thwaites GE, Stepniewska K, Soni N, White NJ, Farrar JJ. Magnesium sulphate for treatment of severe tetanus: a randomised controlled trial. Lancet. 2006 Oct 21;368(9545):1436-43. doi: 10.1016/S0140-6736(06)69444-0.
- Background: PubMed 5630851Ildirim I. A new treatment for neonatal tetanus. Antitetanic serum and prednisolone given together intrathecally. Turk J Pediatr. 1967 Jul;9(3):89-95. No abstract available.
- Background: PubMed 24045402St-Amour I, Pare I, Alata W, Coulombe K, Ringuette-Goulet C, Drouin-Ouellet J, Vandal M, Soulet D, Bazin R, Calon F. Brain bioavailability of human intravenous immunoglobulin and its transport through the murine blood-brain barrier. J Cereb Blood Flow Metab. 2013 Dec;33(12):1983-92. doi: 10.1038/jcbfm.2013.160. Epub 2013 Sep 18.
- Background: PubMed 11880654Miana-Mena FJ, Roux S, Benichou JC, Osta R, Brulet P. Neuronal activity-dependent membrane traffic at the neuromuscular junction. Proc Natl Acad Sci U S A. 2002 Mar 5;99(5):3234-9. doi: 10.1073/pnas.052023599.
- Background: PubMed 22738111Sancho A, Melchiorri D, Abadie E; Committee for Medicinal Products for Human Use, European Medicines Agency. More on influenza vaccine in young children. N Engl J Med. 2012 Jun 28;366(26):2528; author reply 2528-9. doi: 10.1056/NEJMc1205643. No abstract available.
- Background: PubMed 11807088Lalli G, Schiavo G. Analysis of retrograde transport in motor neurons reveals common endocytic carriers for tetanus toxin and neurotrophin receptor p75NTR. J Cell Biol. 2002 Jan 21;156(2):233-9. doi: 10.1083/jcb.200106142. Epub 2002 Jan 21.
- Background: PubMed 18139406FRIEDEMANN U, TRAUB FB. Pathogenesis of local tetanus in the dog and the cat. J Immunol. 1949 Sep;63(1):23-8. No abstract available.
- BackgroundRoux E, Borrel A. Tetanos Cerebral et immunite contre le tetanus. Ann Inst Pasteur (Paris) [Internet]. 1898;12(4):525-35. Available from: https://archive.org/stream/annalesdelinstit12inst
- BackgroundFlorey H, Fildes P. Tetanus . -Vii . the Treatment of Tetanus in Rabbits By Large Intrathecal Doses of Antitoxin . Br J Exp Pathol. 1927;(October):393-7
- Individual participant dataSharing planned: Undecided
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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.
Minh Yen Lam, MD principal investigator
Oxford University Clinical Research Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Human tetanus immunoglobulin and Intramuscular antitoxin in people with Tetanus, run by Oxford University Clinical Research Unit, Vietnam at 1 site in Vietnam.
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 6 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 29 May 2020. 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 Vietnam. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Requirement for mechanical ventilation during ICU stay (time frame: During ICU stay, an average of 3 weeks). 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 NCT02999815, which also lists 57 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 29 May 2020.