Clinical MedicineRMRIMS, Patna

The division of Clinical Medicine is the oldest division of ICMR-RMRIMS, Patna. This division has been a referral centre for the diagnosis and clinical management of visceral leishmaniasis (VL), post-kala-azar dermal leishmaniasis (PKDL) and VL-HIV co-infection. We run 5-days a week OPD services for general patients and round-the-clock indoor services for VL/PKDL/VL-HIV patients at Samrat Ashoka Tropical Disease Research Centre (SATDRC). Time and again ICMR-RMRIMS, Patna has come forward and served the people of Bihar and its neighbouring states under the leadership of the division of clinical medicine for various health crisis viz. Japanese encephalitis, acute encephalitis syndrome (Chamki fever), dengue,chikungunya, swine flu, hepatitis-B & C, tuberculosis, HIV, and currently COVID-19. The division has been commissioned with one of the recognised nodal ART plus centres, OST centres, 1st-line DoT’s centres for tuberculosis diagnosis and treatment. Our central diagnostic laboratory (CDL) is accredited by the NABL under its Basic Composite-Entry Level scheme. We’ve successfully conduted clinical drug trials viz. miltefosine, paromomycin, liposomal amphotericin-B, fungisome, amphomul and combination therapy for VL, PKDL and VL-HIV coinfection, and pharmacovigilance of the antileishmanial drugs have strengthened the treatment strategies under elimination program. We successfully conducted SII/ICMR sponsored phase 2/3 study of COVISHIELD (COVID-19 vaccine) as one of the clinical sites. During initial phase of mass level vaccination drive, we performed telephonic monitoring of ADRs in people vaccinated with COVAXIN in Bihar & Jharkhand. Further, COVID-19 vaccination centre was started on 09th Feb 2021. We also participated in national and state level sero-surveys for COVID-19 in selected districts of Bihar and validation of Rapid Antibody Kits for COVID-19.

Clinical scientists of ICMR-RMRIMS, Patna has recently developed a training module for the Indian Medical Graduate on rational use of drug for leishmaniasis which has been endorsed by the Secretary DHR & Director General, ICMR. ICMR-RMRIMS, Patna is in the process of becoming a WHO collaborative centre for leishmaniasis. Moreover, ICMR-RMRIMS, Patna is being developed as a Centre of Excellence (CoE) for the diagnosis and clinical management of VL, PKDL and VL-HIV. We’ve been mentoring various doctoral theses on leishmaniaisis with overarching themes including clinical, epidemiological, socio-behavioral and molecular aspects.

• Five days a week OPD services for general patients and round the clock indoor services for VL, PKDL and VL-HIV patients in SATDRC
• Intensive care unit (five beds)
• Routine laboratory diagnostic services at NABL accredited central diagnostic laboratory
• Digital X-ray
• 12-lead ECG
• Nodal ART plus centre
• OST centre
• 1st-line DoT’s centre

• The outcome of various clinical drug trials resulted into more options for VL treatment. Introduction of Single Dose AmBisome® (10 mg per kg b.wt.) as first line drug and combination therapy of miltefosine as alternative regimen in national program is of most importance. Though miltefosine is supposed to have teratogenic effect, but no untoward effect observed in the female patients who became pregnant during or after the treatment with miltefosine under the pharmacovigilance study. Retinal dysfunction has been observed in few miltefosine-treated PKDL cases.
• Apart from this, Amphomul has been registered as one of the drugs for VL. Amphotericin B 0.5 mg/ kg b.wt. may be used instead of 1 mg/kg b.wt. for safe treatment of PKDL.
• Asymptomatic cases may have a potential role in disease transmission. We’ve demonstrated that, for improved surveillance, trained field workers at local level and ASHAs may be engaged in active case detection at peripheral level.
• New combination therapies (Miltefosine & AmBisome®) for the treatment of VL/PKDL and HIV-VL.
• Treatment guideline of PKDL has already been communicated to the NVBDCP, New Delhi.
• A clinical trial on 150 patients of HIV-VL was done in collaboration with MSF, India. A total dose of 40 mg/kg body weight of AmBisome® was compared with 30 mg/kg plus 14 days of miltefosine standard dose. The cure rate and survival rate were better in the combination arm as compared to mono-therapy arm.
• Similarly, combination therapy of liposomal amphotericin B and miltefosine is being tried in PKDL in collaboration with DNDi.
• Clinical drug trial on Saroglitazar 4mg in HIV lipodystrophy revealed that Saroglitazar 4mg improves the lipodystrophy condition in HIV patients.
• Apart from Kala-azar, new epidemiological studies on pulmonary TB (PTB) and latent TB (LTB) in tribal population were conducted. A study in malnourished children attending the NRC centres of tribal area has also been undertaken.
• We’ve been the mentor institute for NIPER, Hajipur and have supervised MPharm and PhD students of pharmacy practice department of NIPER-HJP. Three PhD degree have been awarded.

• Assessment of the safety and efficacy of AmBisome® in the dose of 5 mg/kg for three injection with miltefosine for six weeks vs. miltefosine alone for 12 weeks in patients with post kala-azar dermal leishmaniasis (PKDL) – an observational pilot study.
• An Open label, Randomized, Clinical Trial of Two Regimens to Assess the Safety and Efficacy for Treatment of PKDL Patients in the Indian subcontinent. (Phase-II)
• A phase III, open label, randomized trial of three single dose treatment regimens of FungisomeTM (either alone or in combination with miltefosine) compared with a single dose treatment regimen of AmBisome®, for Visceral leishmaniasis (VL) in India.
• A phase II, randomized, controlled, partially blinded study to assess the efficacy and safety of two LXE408 regimens for treatment of patients with primary visceral leishmaniasis in India.
• Developing Centres of Excellence (COE) for Visceral Leishmaniasis (VL) case management in India.
• Assessment of treatment outcomes of VL & HIV patients, predisposing factors for co-morbidity, factors affecting outcomes and health seeking behaviour of co-morbid cases in Bihar: a cross-sectional survey.
• IDDO-ICMR Joint Project for Capacity Building of Young Researchers

Email: pandey.krishna@icmr.gov.in