Eligibility Criteria for the Use of Delamanid [Dlm] in MDR/RR-TB Treatment​

The inclusion and exclusion criteria for the use of Delamanid (Dlm) drug for Multidrug-resistance (DR)/ Rifampicin-resistance (RR) -TB patients are as follows:

Additional Considerations for Inclusion

• Dlm may be considered with caution by the Nodal (N)/ District DR-TB Centre (DDR-TBC) committee under specialist consultation in patients with baseline serum albumin <2.8 g/dl. Frequent monitoring of serum albumin is needed.
• Special caution is also required for HIV+ (in consultation with anti-retroviral treatment (ART) centres), 65 years+, patients with diabetes, hepatic or severe renal impairment, or those who use alcohol or substances. Patients with controlled stable arrhythmia can also be considered after obtaining cardiac consultation.
• Electrolyte imbalances (Serum Potassium (K), Magnesium (Mg), Calcium (Ca)) should be corrected before initiating Dlm.
• Females using a birth control method can also be considered.

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Resources

• Guidelines for Programmatic Management of Drug-resistant Tuberculosis in India, March 2021.
• World Health Organization. The use of Delamanid in Treatment of Multidrug-resistant Tuberculosis: Interim Policy Guidance, 2016.
• Guidelines for the Use of Delamanid in the Treatment of Drug Resistant TB in India, 2018.
• Consolidated Guidelines on Tuberculosis, Module 4- Treatment: Drug Resistant TB Treatment.

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