Post kala-azar dermal leishmaniasis (PKDL) is a neglected complication of visceral leishmaniasis (VL)―a deadly, infectious disease that claims approximately 20,000 to 40,000 lives every year. PKDL is thought to be a reservoir for transmission of VL, thus, adequate control of PKDL plays a key role in the ongoing effort to eliminate VL. Over the past few years, several expert meetings have recommended that a greater focus on PKDL was needed, especially in South Asia. This report summarizes the Post Kala-Azar Dermal Leishmaniasis Consortium Meeting held in New Delhi, India, 27–29 June 2012. The PKDL Consortium is committed to promote and facilitate activities that lead to better understanding of all aspects of PKDL that are needed for improved clinical management and to achieve control of PKDL and VL. Fifty clinicians, scientists, policy makers, and advocates came together to discuss issues relating to PKDL epidemiology, diagnosis, pathogenesis, clinical presentation, treatment, and control. Colleagues who were unable to attend participated during drafting of the consortium meeting report.
BackgroundThis study was conducted in Bangladeshi patients in an outpatient setting to support registration of Paromomycin Intramuscular Injection (PMIM) as a low-cost treatment option in Bangladesh.MethodologyThis Phase IIIb, open-label, multi-center, single-arm trial assessed the efficacy and safety of PMIM administered at 11 mg/kg (paromomycin base) intramuscularly once daily for 21 consecutive days to children and adults with VL in a rural outpatient setting in Bangladesh. Patients ≥5 and ≤55 years were eligible if they had signs and symptoms of VL (intermittent fever, weight loss/decreased appetite, and enlarged spleen), positive rK39 test, and were living in VL-endemic areas. Compliance was the percentage of enrolled patients who received 21 daily injections over no more than 22 days. Efficacy was evaluated by initial clinical response, defined as resolution of fever and reduction of splenomegaly at end of treatment, and final clinical response, defined as the absence of new clinical signs and symptoms of VL 6 months after end of treatment. Safety was assessed by evaluation of adverse events.Principal FindingsA total of 120 subjects (49% pediatric) were enrolled. Treatment compliance was 98.3%. Initial clinical response in the Intent-to-Treat population was 98.3%, and final clinical response 6 months after end of treatment was 94.2%. Of the 119 subjects who received ≥1 dose of PMIM, 28.6% reported at least one adverse event. Injection site pain was the most commonly reported adverse event. Reversible renal impairment and/or hearing loss were reported in 2 subjects.Conclusions/SignificancePMIM was an effective and safe treatment for VL in Bangladesh. The short treatment duration and lower cost of PMIM compared with other treatment options may make this drug a preferred treatment to be investigated as part of a combination therapy regimen. This study supports the registration of PMIM for use in government health facilities in Bangladesh.Trial RegistrationClinicalTrials.gov identifier: NCT01328457
COVID-19 vaccination campaigns have been launched across the globe to mitigate the impact of the COVID-19 disease. However, COVID-19 vaccination campaigns (Vaccination campaigns are the complete process of COVID-19 vaccination campaigns beyond just administrating vaccines.) are a complex multi-stakeholder process, and therefore, it is important to understand the key components and drivers of vaccination campaigns to help devise strategies to increase vaccination coverage for existing and future vaccination efforts. A system dynamics modeling approach was used to trace the vaccination campaign for the Indian state of Madhya Pradesh. The results identified the key stakeholders of the vaccination campaign and their inter-linkages, and the diverse perspectives of stakeholders of vaccination campaigns in Madhya Pradesh were collated in a structured format. Further, system dynamics models were developed to capture all aspects of the vaccination campaign in Madhya Pradesh, including the challenges and innovations. The outcomes of the study can assist academicians, practitioners, and policymakers develop vaccination programs at sub-national, national, and global levels. They will guide decision-makers to take preemptive measures to mitigate possible risks and challenges and provide improved services as part of vaccination campaigns.
We used the introduction of the Japanese encephalitis (JE) vaccine in India as an example to understand more fully the process of introducing any new clinical product in India. We discuss the key decision-making points as well as the many activities involved in introducing a new clinical product in India’s public health program. We write from our experience in supporting the government of India to introduce new products successfully—namely, vaccines—to India’s health system. In India, the process begins with identifying the public health problem (e.g., an outbreak of JE), deciding to take action, prioritizing where action is needed, securing a supply and price of the intervention (the vaccine; in this case, the live, attenuated SA 14-14-2 vaccine), and determining how to ensure effective rollout of the intervention (the vaccination program). Reflecting on the experience of the JE vaccination program helped to inform the introduction of the triple-drug therapy of ivermectin, diethylcarbamazine, and albendazole in India as a new treatment protocol for lymphatic filariasis.
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