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Tests to predict causal drug in drug reactions to antibiotics

In-vitro model to predict causal agent in drug hypersensitivity to antibiotics: potential tests based on measurement of drug-specific T cell response

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/11/022124
Enrollment
130
Registered
2019-11-22
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L99- Other disorders of skin and subcutaneous tissue in diseases classified elsewhere

Interventions

Intervention1: Nil: Nil

Sponsors

Jawaharlal Institute of Post graduate Medical Education and Research JIPMER Puducherry
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Cases Subjects of more than 7 years of age, with a history of delayed cutaneous adverse drug reaction to antibiotics, classified as per as WHO-UMC drug causality assessment as certain/ probable, in clinical remission atleast 3 weeks after the acute event Controls Subjects more than 7 years of age, who had been exposed to and tolerated the corresponding antibiotics as the cases in the last twelve months without a history of drug hypersensitivity.

Exclusion criteria

Exclusion criteria: Patients on immunosuppressive treatment till 2 weeks before recruitment, known immunodeficiency states

Design outcomes

Primary

MeasureTime frame
1. To determine the diagnostic accuracy of Interferon gamma-Intracellular cytokine staining (IFN-γ-ICS) and cytokine bead array (CBA) in predicting the causal drug in drug hypersensitivity reactions. 2. To compare the utility of the IFN-γ ICS and CBA in terms of culprit drug confirmation in drug hypersensitivity reactions Timepoint: 3 years

Secondary

MeasureTime frame
NilTimepoint: Nil

Countries

India

Contacts

Public ContactSivaranjini R

Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)

siva11rsamy@yahoo.com9994085511

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026