Tetanus Severity Score for Prediction of Mortality in Manifest Tetanus

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.

Study Overview

• Status: Recruiting
• Conditions: Tetanus, Manifest
• Intervention / Treatment: Diagnostic test: Tetanus Severity Score (TSS); Diagnostic test: Philips Score; Diagnostic test: Dakar Score

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 Type: Observational
• Enrollment (Estimated): 115

Contacts and Locations

• Study Contact: Name: Sameh M Hakim, MD; Phone Number: +202 26900073; Email: hakimsm@med.asu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11341
    • Recruiting
    • Ain Shams University Hospitals & Demanhour Fever Hospital
    • Contact: Sameh M Hakim, MD; Phone Number: +202 26900073; Email: hakimsm@med.asu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adults of both sexes with manifest tetanus.

Description

Inclusion criteria:

• 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

Exclusion criteria:

• 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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-survivors; Patients who die in hospital	Diagnostic test: 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: Philips Score; The Philips Score is calculated for each patient by the investigator using the required data as documented in the medical records at admission; Diagnostic test: Dakar Score; The Dakar Score is calculated for each patient by the investigator using the required data as documented in the medical records at admission
Survivors; Patients who survive to hospital discharge	Diagnostic test: 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: Philips Score; The Philips Score is calculated for each patient by the investigator using the required data as documented in the medical records at admission; Diagnostic test: Dakar Score; The Dakar Score is calculated for each patient by the investigator using the required data as documented in the medical records at admission

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Sameh M Hakim, MD, Ain Shams University Faculty of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2026
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 15, 2026

Study Registration Dates

• First Submitted: March 24, 2026
• First Submitted That Met QC Criteria: April 1, 2026
• First Posted (Actual): April 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Tetanus, Tetanus Severity Score
• Additional Relevant MeSH Terms: Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Clostridium Infections; Tetanus
• Other Study ID Numbers: FMASU MS 433/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: May be provided upon reasonable request from the principal investigator

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No