AnthraxNCT06365073
A Case-control Study on the Clinical Characteristics of 28-day and 90-day Death From Severe Anthrax
An observational study of Anthrax, run by Qin Ning at 1 site in China.
Trial summary
This study is a clinical, multi-center, retrospective, case-control study. Patients clinically diagnosed with severe anthrax who meet the inclusion and exclusion criteria will be included in this study for analysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anthrax
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 13 Mar 2024to 31 Dec 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with severe anthrax
Who may be able to join
- The typical bacilli with capsules were found in smear examination and culture of various secretions, excretions, blood and cerebrospinal fluid.
- Multiple organ dysfunction (MODS) in brain, heart, liver, kidney, coagulation or more than one organ failure.
Who cannot join
- There are other conditions that affect short-term survival.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Qin Ning, PHD,MD, +8602783662391, qning@vip.sina.com
Qin Ning, PHD,MD
About this study
This study is a clinical, multi-center, retrospective, case-control study. Patients clinically diagnosed with severe anthrax who meet the inclusion and exclusion criteria will be included in this study for analysis. Respiratory, circulation, nerve and other vital signs of patients with severe anthrax during hospitalization were recorded, and clinical data such as blood routine, blood biochemistry, coagulation function, myocardial injury, therapeutic drug use, and survival time of patients were recorded, as well as the survival situation of patients 28 days and 90 days after discharge.
- Conditions
- Anthrax
- Medical subject headings
- Anthrax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| survival group | Patients who survived in 28 days/90 days | |
| death group | Patients who survived in 28 days/90 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality rates of severe anthrax
mortality rates of severe anthrax
Measured: 28 days and 90 days
Secondary outcomes (3)
incidence of complications
To evaluate the incidence of respiratory, circulatory, neurological, digestive, coagulation and other complications of severe anthrax
Measured: in hospital
Peripheral blood biomarkers associated with 28-day and 90-day mortality
Peripheral blood biomarkers associated with 28-day and 90-day mortality
Measured: 28 days and 90 days
the improvement in 28-day and 90-day mortality with treatment for severe anthrax
the improvement in 28-day and 90-day mortality with treatment for severe anthrax
Measured: 28 days and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start13 Mar 2024
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnthraxStudies 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
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qin Ning
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qin Ning, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06365073
- Sponsor's protocol ID
- TJIRB20231276
- Status last verified
- Apr 2024
- First submitted
- 10 Apr 2024
- Last updated
- 15 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Case-control Study on the Clinical Characteristics of 28-day and 90-day Death From Severe Anthrax
- ClinicalTrials.gov ID
- NCT06365073
- Acronym / sponsor ID
- TJIRB20231276
- Conditions
- Anthrax
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Qin NingUniversity, hospital or other
- Study start
- 13 Mar 2024 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 15 Apr 2024 (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.
This study is a clinical, multi-center, retrospective, case-control study. Patients clinically diagnosed with severe anthrax who meet the inclusion and exclusion criteria will be included in this study for analysis. Respiratory, circulation, nerve and other vital signs of patients with severe anthrax during hospitalization were recorded, and clinical data such as blood routine, blood biochemistry, coagulation function, myocardial injury, therapeutic drug use, and survival time of patients were recorded, as well as the survival situation of patients 28 days and 90 days after discharge.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| survival group | – | –Patients who survived in 28 days/90 days |
| death group | – | –Patients who survived in 28 days/90 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with severe anthrax
Key inclusion criteria (2 listed)
- The typical bacilli with capsules were found in smear examination and culture of various secretions, excretions, blood and cerebrospinal fluid.
- Multiple organ dysfunction (MODS) in brain, heart, liver, kidney, coagulation or more than one organ failure.
Key exclusion criteria (1 listed)
- There are other conditions that affect short-term survival.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
mortality rates of severe anthrax
Time frame: 28 days and 90 days
mortality rates of severe anthrax
3 secondary outcomes
incidence of complications
Time frame: in hospital
Peripheral blood biomarkers associated with 28-day and 90-day mortality
Time frame: 28 days and 90 days
the improvement in 28-day and 90-day mortality with treatment for severe anthrax
Time frame: 28 days and 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
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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.
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 Anthrax, run by Qin Ning 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 2 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 15 Apr 2024. 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 Qin Ning, professor (027-83665919, qning@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality rates of severe anthrax (time frame: 28 days and 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Apr 2024.