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Digoxin in patients with rheumatic heart disease – a randomised placebo-controlled trial
This is a multi-centre, placebo-controlled, parallel-group randomized, double blind trial of digoxin in patients with RHD. Patients will be randomized to receive usual medical therapy with digoxin or placebo. The study will be conducted at 10 public hospitals in India. The data management and statistical unit at the Indian Institute of Public Health – Delhi (IIPH-D) will be responsible for developing the web-based randomization and data entry interfaces, management of study data, and statistical analysis.
|Funding Agency :||Indian Council of Medical Research (ICMR), New Delhi|
|Sponsor :||All India Institute Of Medical Sciences, New Delhi|
|CDSA Role :||CDSA is responsible for study start-up support, quality management through clinical and safety monitoring.
Key contributions: Codal formalities and IEC approval accomplished at 5 sites (AIIMS, GB Pant Delhi, IG Shimla, SCTIMST Trivandrum and Shri Jayadeva Bangalore).
|Project Status :||Recuitment ongoing|
|Study Sites :||
National Biopharma Mission (NBM) is an academia-industry collaborative mission for accelerating discovery research to early development for biopharmaceuticals co-funded by Department of Biotechnology (Ministry of Science & Technology, Government of India) and being implemented by Biotechnology Research Assistance Council (BIRAC). Major objectives of the mission are expected to ensure affordability and accessibility of biologicals for the Indian population. As part of multipronged strategy to realise the objectives of the mission the two key initiatives are Establishing Clinical Trial Network for Hospital based Trials in specialties of Diabetology, Ophthalmology, Rheumatology and Oncology for trials in patients for testing Biologicals and Strengthening Clinical Trial Capabilities for vaccine efficacy trials in healthy population cohort.
|Funding Agency :||Department of Biotechnology (Govt. of India) and World Bank Group|
|Sponsor :||National Biopharma Mission, BIRAC|
|CDSA Role :||CDSA is providing technical support and consultancy for;
Key contributions: After receiving overwhelming response for request for proposals the evaluation (technical, legal and financial) has been completed for applicants and grants are being disbursed. A longitudinal seroprevalence study of Covid-19, Dengue & Chikungunya is to commenced at RFP-2 sites very shortly.
|Project Status :||Evaluation of proposals including technical & financial due diligence is completed. Five ‘existing DSS/DHS/DDESS’ sites have been identified for conduct of epidemiological and community-based clinical trials. Research Protocol for longitudinal seroprevalence study of Covid-19, Dengue & Chickungnya is being finalized. Capacity building at new DSS/DHS/DDESS sites is undergoing.
Establishment of clinical trial networks is also under process; a registry program shall be commenced at all participating sites of respective CTN.
|Study Sites:||RFP-2 (Existing DSS/DHS/DDESS Sites): Five sites
RFP-3 ((New DSS/DHS/DDESS Sites): Six sites
RFP-2 (Clinical Trial Networks): 36 sites
Translational Research Consortium for Establishing Platform Technologies to Support Prophylactic and Therapeutic Strategies for Dengue – Discovery to Proof-of-Concept
The overall goal of this Dengue TRC is to assemble, coordinate and develop research capacity, reagents, assays, and resources needed for testing and evaluation of dengue vaccine candidates in the future; while in parallel making efforts for generating human monoclonal antibodies and explore their prophylactic / therapeutic potential in pre-clinical animal models.
The clinical sites will recruit 100 well-characterized confirmed dengue children and adults from AIIMS and CMC each year for obtaining peripheral blood samples at two time points within the acute febrile time point, along with follow up with one at 1-month recovery. For assembling asymptomatic samples, MAHE will screen within their already established area by taking verbal survey and finger prick rapid screening for NS1 antigen. Individual’s positive for NS1, but with no clinical symptoms will be considered to be asymptomatic.
|Funding Agency :||National Biopharma Mission (NBM)|
|Sponsor :||International Centre For Genetic Engineering And Biotechnology (ICGEB)|
|CDSA Role :||The responsibility of CDSA is Quality control of study conduct at clinical sites, data management and administrative support for the program management.
|Project Status :||Ongoing|
Burden of multidrug-resistant neonatal sepsis in district hospital settings in India
The purpose of this study is to determine the epidemiology of neonatal sepsis in secondary level/district hospitals. This study is conducted in level II special new-born care units (SNCU) of five district hospitals. The major objective is to understand the sepsis burden, pathogen profile and antimicrobial resistance pattern in neonates admitted to these SNCUs. All the neonates (inborn and outborn) admitted in the study hospitals will be enrolled and tracked for the occurrence of sepsis. In neonates with suspected sepsis, clinical work up, isolation of pathogens and antibiotic susceptibility test will be done as per the defined standard operating procedures. The neonates will be tracked for final outcome until death or 28 days of age.
|Funding Agency :||BMGF|
|Sponsor :||AIIMS, Delhi|
|CDSA Role :||CDSA is responsible for project management, quality management, data management and financial management. Key contributions:
The follow-up study to evaluate the impact of continuous KMC initiated immediately after birth compared to KMC initiated after stabilization in new-borns with birth weight 1.0 to <1.8 kg on their neurodevelopmental outcomes in low-resource settings
The main hypothesis is that neonates with birth weight 1.0 to <1.8 kg, who are exposed to continuous KMC initiated immediately after birth, will experience decreased risk of neurodevelopmental impairment compared to neonates in whom KMC is initiated after stabilization. The effect of this intervention on long-term outcomes such as motor or sensory disability or cognitive deficits is not known. We, therefore, propose to do a follow-up study of new-borns enrolled in the already approved immediate KMC study to 2 years of age, in order to assess the impact on neurodevelopmental impairment and other outcomes such as growth, parental interactions and mortality beyond the neonatal period.
|Funding Agency :||WHO (BMGF)|
|CDSA Role :||CDSA is responsible for quality management, financial management and clinical data management.
Key contributions: Vardhaman Mahavir Medical College (VMMC) and Safdarjung Hospital (SJH) has collaborated with CDSA for the conduct of this extension study. The study is ongoing and is conducted in compliance with GCP and WHO guidelines.
|Study Sites:||Vardhman Mahavir Medical College & Safdarjung Hospital (VMMC & SJH), New Delhi, India|
A Phase III, Randomized, Double-blind, Three arm Placebo controlled Trial to Evaluate the Efficacy and Safety of two vaccines VPM1002 and Immuvac(Mw) in Preventing Tuberculosis (TB) in Healthy Household Contacts of Newly Diagnosed Sputum Positive Pulmonary TB Patients.
To evaluate the efficacy of VPM1002 and Immuvac by comparing reduction in the incidence of TB over 3-year period among Indian healthy household contacts of newly diagnosed sputum positive PTB patients vaccinated with VPM1002 and Immuvac in comparison to placebo.
|Funding Agency :||ICMR|
|CDSA Role :||CDSA is responsible for study start-up and site monitoring|
|Project Status :||Ongoing|
|Study Sites :||Prof. Randeep Guleria, Director, AIIMS, New Delhi
Dr. RohitSarin (NITRD, Delhi)
Dr. Sindhu Joshi, Director, BMMRC, Hyderabad
Dr. N. Somashekar, Director, NTI, Bengaluru, Karnataka
Dr. Samiran Panda, Director, ICMR, NARI, Pune, Maharashtra
Dr. Sanghamitra Pati, Director, ICMR-RMRC Bhubaneswar, Odisha
Dr. Srikanth Tripathy, Director, ICMR, NIRT Chennai, Tamil Nadu
Garbh-INI – Interdisciplinary Group for Advanced Research on BirtH outcomes – DBT INdia Initiative (PTB)
Unique collaborative interdisciplinary program between research institutes (Translational Health Science and Technology Institute, National Institute of Biomedical Genomics, Kalyani; Regional Centre for Biotechnology, Delhi NCR, and district Gurugram Civil Hospital (GCH), Haryana) and tertiary care hospitals (Safdarjung Hospital (SJH), Maulana Azad Medical College, New Delhi. This study is coordinated by the Paediatric Biology Centre at THSTI. Globally, preterm birth is a major public health problem. In India, annually about 13% (3.6 million of 27 million) of all babies born are preterm. About 300,000 of preterm babies die each year because of complications, contributing to 25% of the overall global preterm-related deaths. The adverse consequences of preterm birth (PTB) extend beyond early infancy with substantial consequences later in life. Effective solutions have not been possible because PTB is a complex syndrome with multiple aetiologies that include interacting biological, psychosocial and environmental factors. Risk stratification of women based on multidimensional risk factors assessed during pregnancy is critical for prevention of preterm birth. To address this, an interdisciplinary Group Garbh-Ini has been established across DBT autonomous research institutes and hospitals. A cohort of pregnant women was started in May 2015 at the Civil Hospital in Gurugram, Haryana, with the objectives to identify the clinical, epidemiological, genomic, epigenomic, proteomic and microbial correlates, discover molecular risk-markers by using an integrative omics approach, and generate a risk-prediction algorithm for preterm birth.
|Funding Agency :||Department of Biotechnology|
|Sponsor :||Department of Biotechnology|
|CDSA Role :||CDSA supported setting up a co-ordination unit for site preparation, role-based training, and standardized processes to ensure efficient implementation and compliance. CDSA is ensuring the quality of this study by conducting the monitoring activities.
|Project Details and Project Status :||
This is a prospective longitudinal nationwide study to understand the clinical course, severity, risk factors
and outcomes of patients affected with various strains of SARS-CoV2 and to provide robust data to guide
policy and public health response. An important objective is to study the viral genome sequencing and to
link molecular epidemiology of SARS- CoV-2 to clinical outcomes.
|Funding Agency :||Department of Biotechnology, Ministry of Science and Technology, Government of India|
|Sponsor :||Translational Health Science and Technology Institute (THSTI), (Coordinating Centre)|
|CDSA Role :||CDSA is responsible for project management, quality management, data management and financial management|
|Project Status||Recruitment ongoing|
Effective and affordable flu vaccine for the world
Despite the availability of flu vaccines for decades, influenza is still an important disease in both developing and developed countries with 500,000 casualties annually and many more people affected. From a global health perspective, the lack of effectivity, availability, affordability and accessibility of flu vaccines significantly limits our ability to respond to the seasonal flu every year and in the event of a pandemic. Currently, a low vaccine effectivity of 40% implies that 60% of vaccinated people are not sufficiently protected, with low confidence further contributing to limited uptake/immunization. In this project, public and private R&D organizations in India, EU and US collaborate on the development of two novel influenza vaccine concepts that meet the requirements of global vaccination, aiming to achieve <10% instead of 60% non-responders, lower costs, and better accessibility.
The first approach combines a low dose of a commercial, inactivated, seasonal flu vaccine with a novel, potent adjuvant, and will deliver
proof-of-concept in Phase I and IIa trials within 5 years.
The second approach builds on three innovations:
Contra-productive parts of HA will be removed to increase the immunogenicity of neutralizing epitopes. The adjuvant further stimulates protective immunity and immunological memory. The use of intradermal patches opens possibilities for self-administration, which will improve vaccine uptake in developing as well as developed countries. With proven nonclinical immunogenicity and safety, we will embark on clinical development of this concept after completion of the project.Various partnering institutesare working towards establishing a proof-of-concept for furtherCHIM and pre-clinical studies.
|Funding Agency:||Department of Biotechnology, Ministry of Science and Technology, Government of India|
|Sponsor :||Department of Biotechnology, Ministry of Science and Technology, Government of India|
|CDSA Role :||CDSA’s responsibility involves coordination between the various stakeholders, as a dissemination agency, developing SOPs, essential documents and monitoring of the Phase I and IIa trials.
CDSA team has set up a robust communication plan as well as a dissemination protocol to facilitate timely exploitation of the generated information
|Project Status :||Ongoing|
|Study Sites (INDIA) :||
A multi-disciplinary, multi-institutional research program for context-specific solutions
The program has two phases. In the first phase to be conducted over a period of five years,there are 10 projects on discovery research. The second phase shall involve validation of the results and leads obtained during the program’s first phase over the next 3-4 years. The program involves multiple stakeholders with expertise in neonatology, microbiology, molecular biology, genomics, immunology, bioinformatics, diagnostics.
The phase one projects will be executed concurrently in the same cohort of neonates enrolled at four clinical sites in Delhi. The nodal center at AIIMS, New Delhi, is the overall coordinator of the program and provides liaison with the project leads and the investigators at the clinical sites and the funding agency (DBT, India). It ensures shared accountability of the program by experts from different disciplines. We plan to enrol a maximum of 250 and 500 neonates with culture-positive sepsis and culturenegative sepsis, respectively, in the program. Assuming 50000 deliveries per year in the four study hospitals, we shall be able to enrol about 125 and 250 neonates with culture-positive and culturenegative sepsis, respectively, in the gestation age group of 28 to 34 weeks. We expect the required sample size to be met within 24 months. Enrolments were initiated in the first quarter of 2022. Another 24 months will be required after the completion of enrolment for final data analysis and interpretation.
|Funding Agency:||Department pf Biotechnology|
|Coordinating site :||All India Institute of Medical Sciences, New Delhi|
|CDSA Role :||
|Project Status :||Ongoing|
|Study Sites :||