Tetanus Severity Score for Prediction of Mortality in Manifest Tetanus

NCT07512167 | Recruiting DMC

• 1 other identifier: FMASU MS 433/2025
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

Three scoring systems will be applied to patients suffering from manifest tetanus and will be related to mortality.

Conditions

Tetanus, Manifest

Keywords

Tetanus, Tetanus Severity Score

Outcome Measures

Primary Outcomes (1)

• Death from any cause.

  Occurrence of death from any cause, assessed from the date of onset of symptoms up to 90 days.

  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.

Study Arms (2)

Non-survivors

Patients who die in hospital

Diagnostic Test: Tetanus Severity Score (TSS); Diagnostic Test: Philips Score; Diagnostic Test: Dakar Score

Survivors

Patients who survive to hospital discharge

Diagnostic Test: Tetanus Severity Score (TSS); Diagnostic Test: Philips Score; Diagnostic Test: Dakar Score

Interventions

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

Non-survivors; Survivors

Philips Score DIAGNOSTIC_TEST

The Philips Score is calculated for each patient by the investigator using the required data as documented in the medical records at admission

Non-survivors; Survivors

Dakar Score DIAGNOSTIC_TEST

The Dakar Score is calculated for each patient by the investigator using the required data as documented in the medical records at admission

Non-survivors; Survivors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults of both sexes with manifest tetanus.

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals & Demanhour Fever Hospital

Cairo, Cairo Governorate, 11341, Egypt

RECRUITING

MeSH Terms

Conditions

Tetanus

Condition Hierarchy (Ancestors)

Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Sameh M Hakim, MD

  Ain Shams University Faculty of Medicine

  STUDY DIRECTOR

Central Study Contacts

Sameh M Hakim, MD

CONTACT

+202 26900073; hakimsm@med.asu.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology, Intensive Care and Pain Management

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: April 6, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): November 15, 2026
• Last Updated: September 29, 2026

Record last verified: 2026-09

Locations

EG (1)