Tetanus, ManifestNCT07512167
Tetanus Severity Score for Prediction of Mortality in Manifest Tetanus
An observational study of Tetanus, Manifest, run by Ain Shams University at 1 site in Egypt.
Trial summary
Three scoring systems will be applied to patients suffering from manifest tetanus and will be related to mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tetanus, Manifest
- What is being tested?
- Tetanus Severity Score (TSS), Philips Score and Dakar Score
- How many people
- 115 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2026to 15 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adults of both sexes with manifest tetanus.
Who may be able to join
- Adults (age 18 years old or more).
- Any sex (male or female), regardless of gender identity.
- Diagnosis of manifest tetanus according to the WHO criteria (https://www.who.int/news-room/fact-sheets/detail/tetanus), that is the presence of one or both of the following criteria with or without the history of specific wound or injury:
- Sustained spasm of the facial muscles in which person appears grinning.
- Painful muscular contractions
Who cannot join
- Age < 18 years.
- Absent criteria of manifest tetanus, as per the WHO criteria (https://www.who.int/news-room/fact-sheets/detail/tetanus).
- Incomplete medical record with missing data required to calculate the Tetanus Severity Score, Philips Score, or Dakar score.
- Incomplete medical record with missing data regarding the primary outcome measure (survival to hospital discharge or in-hospital mortality).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University Hospitals & Demanhour Fever Hospital
Cairo, Cairo Governorate, 11341
Sameh M Hakim, MD, +202 26900073, hakimsm@med.asu.edu.eg
About this study
Official title: Comparison of Three Scoring Systems for Prediction of Mortality in Patients Admitted to the Intensive Care Unit With Manifest Tetanus
Three scoring systems will be applied to patients suffering from manifest tetanus and will be related to mortality.
Read the detailed description
On admission to the intensive care unit, three scoring systems for tetanus severity will be applied to all patients: the Tetanus Severity Score (TSS), Dakar Score, and Philips Score, and will then be related to the occurrence of in-hospital mortality or survival to hospital discharge.
- Conditions
- Tetanus, Manifest
- Being tested
- Tetanus Severity Score (TSS), Philips Score, Dakar Score
- Keywords
- Tetanus, Tetanus Severity Score
- Medical subject headings
- Tetanus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tetanus Severity Score (TSS)Diagnostic test
The Tetanus Severity Score (TSS) is calculated for each patient by the investigator using the required data as documented in the medical records at admission
Philips ScoreDiagnostic test
The Philips Score is calculated for each patient by the investigator using the required data as documented in the medical records at admission
Dakar ScoreDiagnostic test
The Dakar Score is calculated for each patient by the investigator using the required data as documented in the medical records at admission
| Study group | Role | What they receive |
|---|---|---|
| Non-survivors | Patients who die in hospital Receives: Diagnostic Test: Tetanus Severity Score (TSS); Diagnostic Test: Philips Score; Diagnostic Test: Dakar Score | |
| Survivors | Patients who survive to hospital discharge Receives: Diagnostic Test: Tetanus Severity Score (TSS); Diagnostic Test: Philips Score; Diagnostic Test: Dakar Score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death from any cause.
Occurrence of death from any cause, assessed from the date of onset of symptoms up to 90 days.
Measured: From the date of onset of symptoms until the date of death or date of discharge from the hospital, whichever comes first, assessed up to 90 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start15 Apr 2026
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tetanus, ManifestStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh M. Hakim, Ain Shams University
- Investigators
- Sameh M Hakim, MD, Study director, Ain Shams University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07512167
- Sponsor's protocol ID
- FMASU MS 433/2025
- Status last verified
- Sep 2026
- First submitted
- 24 Mar 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: May be provided upon reasonable request from the principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Three Scoring Systems for Prediction of Mortality in Patients Admitted to the Intensive Care Unit With Manifest Tetanus
- ClinicalTrials.gov ID
- NCT07512167
- Acronym / sponsor ID
- FMASU MS 433/2025
- Conditions
- Tetanus, Manifest
- Keywords
- Tetanus, Tetanus Severity Score
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 6 Apr 2026 (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.
Three scoring systems will be applied to patients suffering from manifest tetanus and will be related to mortality.
Detailed description
On admission to the intensive care unit, three scoring systems for tetanus severity will be applied to all patients: the Tetanus Severity Score (TSS), Dakar Score, and Philips Score, and will then be related to the occurrence of in-hospital mortality or survival to hospital discharge.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-survivors | – | Diagnostic Test: Tetanus Severity Score (TSS), Diagnostic Test: Philips Score, Diagnostic Test: Dakar ScorePatients who die in hospital |
| Survivors | – | Diagnostic Test: Tetanus Severity Score (TSS), Diagnostic Test: Philips Score, Diagnostic Test: Dakar ScorePatients who survive to hospital discharge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults of both sexes with manifest tetanus.
Key inclusion criteria (5 listed)
- Adults (age 18 years old or more).
- Any sex (male or female), regardless of gender identity.
- Diagnosis of manifest tetanus according to the WHO criteria (https://www.who.int/news-room/fact-sheets/detail/tetanus), that is the presence of one or both of the following criteria with or without the history of specific wound or injury:
Key exclusion criteria (4 listed)
- Age < 18 years.
- Absent criteria of manifest tetanus, as per the WHO criteria (https://www.who.int/news-room/fact-sheets/detail/tetanus).
- Incomplete medical record with missing data required to calculate the Tetanus Severity Score, Philips Score, or Dakar score.
- Incomplete medical record with missing data regarding the primary outcome measure (survival to hospital discharge or in-hospital mortality).
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 |
|---|---|---|
| Tetanus Severity Score (TSS)The Tetanus Severity Score (TSS) is calculated for each patient by the investigator using the required data as documented in the medical records at admission | Diagnostic test | Non-survivors, Survivors |
| Philips ScoreThe Philips Score is calculated for each patient by the investigator using the required data as documented in the medical records at admission | Diagnostic test | Non-survivors, Survivors |
| Dakar ScoreThe Dakar Score is calculated for each patient by the investigator using the required data as documented in the medical records at admission | Diagnostic test | Non-survivors, Survivors |
Primary outcome
Death from any cause.
Time frame: From the date of onset of symptoms until the date of death or date of discharge from the hospital, whichever comes first, assessed up to 90 days.
Occurrence of death from any cause, assessed from the date of onset of symptoms up to 90 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: Undecided. May be provided upon reasonable request from the principal investigator
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.
Sameh M Hakim, MD study director
Ain Shams University Faculty of Medicine
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 Tetanus, Manifest, run by Ain Shams University at 1 site in Egypt.
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 5 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: looking for participants now, as of the sponsor's last update on 29 Sep 2026. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sameh M Hakim, MD (+202 26900073, hakimsm@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death from any cause. (time frame: From the date of onset of symptoms until the date of death or date of discharge from the hospital, whichever comes first, assessed up to 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 29 Sep 2026.