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NCT ID: NCT05197725 Not yet recruiting - Covid19 Clinical Trials

Face Masks to Reduce SARS-CoV-2 Infections in Bangladesh

Start date: January 15, 2022
Phase: N/A
Study type: Interventional

The primary goal of the village-level intervention is to assess whether mask-wearing reduces community-level asymptomatic and symptomatic SARS-CoV-2 infections, assessed via PCR testing. The study also examines if community-based activation through values or individual activation through information results in higher mask-wearing.

NCT ID: NCT05180201 Recruiting - Safety Issues Clinical Trials

SEPSIS: L. Plantarum Trial

Start date: January 7, 2022
Phase: Phase 2
Study type: Interventional

Sepsis is a life-threatening clinical syndrome and a leading cause of neonatal deaths worldwide. The burden of neonatal sepsis and severe infection (SI) is particularly high in areas of South Asia and other resource-limited settings. The goal of the Synbiotics for the Early Prevention of Severe Infections in Infants (SEPSIS) phase II L. plantarum trial is to generate knowledge on the safety, tolerability and effects on the microbiome of Lactiplantibacillus plantarum, with or without fructooligosaccharide, in infants (birth to 60 days of age) in Dhaka, Bangladesh. All data generated will support the design and implementation of a phase III trial to test the efficacy of the probiotic/synbiotic or other interventions for the prevention of SI, promotion of optimal growth and development, and effects on other health outcomes in early infancy.

NCT ID: NCT05172817 Recruiting - Clinical trials for Rheumatoid Arthritis

Study to Compare PK & Safety of Advixa With Humira in Healthy, Adult Subject Followed by Efficacy & Safety Study in RA Patients

ACT
Start date: June 2, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

Adalimumab is a recombinant monoclonal antibody (IgG1 subclass) against human TNF-α (Tumor Necrosis Factor-alpha). It is an immunosuppressive medication predominantly used to treat rheumatoid arthritis autoimmune disease. It is also used for the treatment of psoriatic arthritis, ankylosing spondylitis, and Crohn's disease etc. Adalimumab binds specifically to TNF-α and blocks its general cytokine effects, thereby reducing TNF-induced inflammation and halting tissue destruction. Adalimumab was approved for medical use in the United States in 2002. It is on the World Health Organization's List of Essential Medicines. It is available as a biosimilar medication. In 2017, it was the 169th most commonly prescribed medication in the United States, with more than three million prescriptions. Adalimumab is an expensive product which is indicated in rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, etc. Each patient will be provided the study drug free of cost in this study which will benefit them immensely. The advent of therapeutic monoclonal antibodies has given a major boost to the treatment of individuals suffering from autoimmune disorders, including rheumatoid arthritis. Adalimumab is one such therapeutic monoclonal antibody used for treatment of rheumatoid arthritis marketed with brand name Humira by Abbvie Ltd. (USA) was the only adalimumab biosimilar available for patients in Bangladesh until recently. Incepta Pharmaceuticals Ltd. Bangladesh has introduced Bangladesh's first locally manufactured adalimumab biosimilar Advixa that is available at a fraction of Humira's cost. This study aims to evaluate the pharmacokinetics, safety and efficacy of the Adalimumab biosimilar (Advixa) in comparison to Adalimumab (Humira) as reference. The biosimilar Advixa being a local product will a cost-effective alternative to imported drugs currently available in the market. Objectives of the Protocol General objectives- 1. To assess the Pharmacokinetic between Test Product (A): Adalimumab (Advixa) 40 mg/ 0.4 ml of Incepta Pharmaceuticals Ltd of Bangladesh and the corresponding Reference Product (B): Humira 40 mg/ 0.4ml of Abbvie Ltd in normal, healthy, adult, human subjects in a Parallel group study. 2. To evaluate the safety between two products. 3. To assess efficacy, tolerability and safety of biosimilar adalimumab (Advixa, Incepta) in compared with reference adalimumab (Humira, AbbVie) in patients with moderate to severe rheumatoid arthritis (RA). Specific objectives- 1. Pharmacokinetic (PK) Parameters: For Cmax and AUC0-t the 90% confidence interval for the ratio of the test and reference products should be contained within the acceptance interval of 80.00-125.00%. 2. Safety assessment: Evaluation and comparison between references vs. test drug in terms of safety end point. 3. Efficacy assessment: The primary endpoints will be - 1. Proportion of patients with an ACR20 response in both the treatment groups at week 12. 2. Evaluation and comparison of safety between references vs. test drug. The secondary endpoints will be - 1. Change in Disease Activity Score of 28 joints - CRP (DAS28-CRP), 2. Proportion of patient with an ACR50 response and 3. Proportion of patients with an ACR70 response in both the treatment groups at week 12.

NCT ID: NCT05163561 Not yet recruiting - Poliomyelitis Clinical Trials

Evaluation of Safety and Immunogenicity of Inactivated Adjuvanted Polio Vaccine in Comparison With Licensed Inactivated Poliovirus Vaccine

Start date: January 10, 2022
Phase: Phase 3
Study type: Interventional

This Phase III study has been designed to compare the SII Inactivated Salk Polio Vaccine (Adsorbed) with Sii licensed IPV by testing the vaccine in infants (three doses administered 4 weeks apart, starting at 6-8 weeks of age) in order to demonstrate the non-inferiority in the induction of specific poliovirus neutralizing antibody (PVNA) to poliovirus type 1, type 2 and type 3 by these vaccines. The study will also evaluate lot-to-lot consistency in the manufacture of SII Inactivated Salk Polio Vaccine (Adsorbed) by demonstrating equivalence in the induction of PVNA across three production lots.

NCT ID: NCT05158842 Recruiting - Covid19 Clinical Trials

Treatment of COVID-19 Positive/Negative Bangladeshi Adults With Severe Respiratory Complaints by a Locally Made bCPAP: Feasibility Study

Adult-bCPAP
Start date: October 8, 2021
Phase: N/A
Study type: Interventional

Low and middle-income countries (LMICs) urgently need cost-effective adaptive technologies to provide CPAP. The lead investigator has designed a device that has already been approved by the Directorate General of Drug Administration (DGDA), Government of the People's Republic of Bangladesh. The design of the nasal seal was comfortable and well tolerated by all the participants. Patients were told about some mild discomfort at higher delivered pressures (14 or 15 cm PEEP), consistent with pressurised nasal delivery by similar devices. The safety phase has been initiated since 1st November 2020 and ended in April 2021. One patient withdrew from the study but none of them developed any adverse events. The feasibility phase started at the end of September 2021. Objectives: 1. To evaluate the barriers and operational challenges related to the introduction of adult bubble CPAP oxygen therapy 2. To evaluate the acceptability of introducing adult bubble CPAP in tertiary level hospitals of Bangladesh

NCT ID: NCT05155436 Not yet recruiting - Hypertension Clinical Trials

Occurrence of Dyskalemia With Treatment for Hypertension

OK
Start date: December 6, 2021
Phase: Phase 4
Study type: Interventional

Hypertension is a major public health issue associated with significant morbidities and mortality. Fixed dose combination (FDC) pills, combining 2 or more classes of antihypertensive medications have considerable appeal because they may reduce blood pressure more effectively and efficiently compared to monotherapy. However, because FDC medication causes 'dyskalemia', the occurrence of either hypo- or hyper-kalemia, which requires laboratory testing, implementing FDC is hampered in some low- and middle-income countries where laboratory testing is limited. This study will be conducted in the area of Mirpur in Dhaka, Bangladesh, to 1) estimate the prevalence of dyskalemia in hypertensive patients who are candidates for pharmacotherapy; and 2) of those patients initiating a FDC combining telmisartan 40 mg/amlodipine 5 mg, estimate the incidence of dyskalemia at two months later. Telmisartan is a widely prescribed drug approved by Directorate General of Drug Administration (DGDA). If the prevalence and incidence of dyskalemia is low, as anticipated, our results will provide evidence that routine laboratory testing might not be necessary. It is to be mentioned that Telmisartan is not a new drug and it is a widely prescribed drug approved by Directorate General of Drug Administration (DGDA), Bangladesh

NCT ID: NCT05150509 Recruiting - Clinical trials for Oral Squamous Cell Carcinoma

Association of Salivary Amino Acid Level With OSCC Identified By Liquid Chromatography Mass Spectroscopy

OSCC
Start date: December 15, 2020
Phase:
Study type: Observational

Oral Squamous Cell Carcinoma (OSCC) is the most common oral malignancy worldwide. The prognosis of the OSCC patient is not significant despite the modern treatment facilities. Late presentation is one of the most crucial cause of this and for that reason, the importance of early diagnosis of OSCC should be the main concern. Till now, incisional biopsy followed by histopathological examination is the gold standard for diagnosis of oral cancer. The aim of the present study is to find out the association of salivary amino acid levels with oral squamous cell carcinoma, whether the levels are increased or decreased in the patient suffering from OSCC. This might be helpful for early diagnosis of oral cancer and better prognosis.

NCT ID: NCT05135026 Not yet recruiting - Clinical trials for Increase Institutional Delivery

Ultrasonography and Health Education Can Reduce the Unnecessary Caesarean Section in Bangladesh

Start date: December 1, 2021
Phase: N/A
Study type: Interventional

A caesarean section (C/S) is a surgical procedure performed to prevent difficulties during childbirth. World Health Organization considered the standard rate for the C/S would be between 10% and 15%. However, since 2000 the rate of C/S was increasing globally, and it became about twofold from 12.1% to 21.1% in 2015. In Bangladesh, C/S continued to increase from 8% (2007) to 33% (2017). Medically unnecessary C/S was estimated about 77% of all C/S in 2018, and it was increased from 66% since 2016. In Bangladesh, unnecessary C/S observed 9.0% and 3.2% C/S done due to avoid labour pain and 5.8% for the convenience of the mother. The economic burden of each C/S is average USD 612 and unfortunately, each patient spends this amount of money from out of pocket. Aim of this study is to do ultrasonography and health education can reduce unnecessary caesarean section among pregnant women compared to control group in a resource poor setting. Investigators will conduct this randomized controlled trial (RCT) at Dhaka and Sir Salimullah Medical College & Hospital, and two rural Upazila Health Complexes (Savar Upazila Health Complex and Munshigonj General Hospital). Investigators will randomly select one urban hospital from two urban hospitals and one rural hospital from two rural hospitals for the intervention. The other one urban and one rural hospital will be assigned as control hospitals. One research staff, who will not involve any of the research activity of this trial, will do this randomization. Pregnant mothers will be identified and recruited during their routine antenatal visits. Pregnant mothers receive 2 USG during their routine ANC visits at 1st visit of 8-12 weeks and 4th visit of 36-38 weeks. In the intervention centres, Investigators will perform additional 4 ANC visits at 20, 30, 36 and 40 weeks (total 8 visits) and USG additional 2 times during the 2nd visit of 24-26 weeks and 5th visit of 34 weeks (2 routine USG + 2 USG in 3rd and 5th ANC visits and even more USG if needed + Health education; pictorial flip chart showing danger sign during pregnancy and potential risks for unnecessary caesarean delivery to increase awareness for safe delivery) for all the enrolled pregnant mothers. In the control centres, Investigators will collect information from the pregnant mothers. Investigators are expecting the pregnant women who will receive antenatal care with ultrasonography and health education will have reduced number of unnecessary C/S compared to control group who will not receive those.

NCT ID: NCT05121974 Not yet recruiting - Shigellosis Clinical Trials

Tebipenem Trial in Children With Shigellosis

Start date: December 2021
Phase: Phase 2
Study type: Interventional

Background (brief): Shigellosis is the second leading cause of death due to diarrheal diseases worldwide (>200,000 deaths/year). Though the mortality rate associated with Shigellosis has decreased, the fact that the bacteria have acquired resistance to multiple antibiotics, is a cause for major concern. Oral azithromycin and intravenous ceftriaxone are the recommend first and second line therapies, respectively in Bangladesh. Approximately 20% of Shigella isolates are resistant to azithromycin suggesting that a substantial number of children will require second-line therapy. While resistance to ceftriaxone in shigellosis is low in Bangladesh at 5%, the potential for rapid emergence of antibiotic resistance to this third-generation cephalosporin and ceftriaxone's resource-intensive delivery method, underscore the need for evidence-based alternative antibiotic regimens for multidrug resistant Shigella infections Hypothesis: Children treated with tebipenem-pivoxil will have no worse clinical and microbiologic failure rates compared to ceftriaxone. Objectives: Primary objective: The proposed study involves aims to determine whether tebipenem-pivoxil is non-inferior to the currently WHO-recommended second line Shigella therapy (ceftriaxone). Secondary objectives: To describe the number of adverse events, between children with shigellosis treated with oral tebipenem-pivoxil or IV ceftriaxone. To compare the prevalence of ceftriaxone and tebipenem-pivoxil resistance, as well as ESBL- and carbapenemase-producing E. coli, in children treated with tebipenem-pivoxil or ceftriaxone 4- and 30-days after initiation of second-line therapy. Methods: Investigators propose a phase IIb randomized controlled trial (RCT) to determine the efficacy and safety of oral tebipenem-pivoxil, compared to IV ceftriaxone, for children with Shigella infections unresponsive to first-line antibiotic therapy. Bangladeshi children aged 24 to 59 months with suspected Shigella infections and no clinical improvement within 48 hours of first-line therapy will be randomized to a 3-day course of oral tebipenem-pivoxil (4 mg/kg 3x daily) or 3-days of IV ceftriaxone (50 mg/kg 1x daily). The children will be evaluated for key clinical, microbiologic, and safety outcomes during the subsequent 30-day period. Additionally, investigators propose a lead in study of 15 patients to confirm the safety profile and pharmacokinetics and efficacy of tebipenem in the study population. During this pharmacokinetic study period investigators will compare 15 children with oral Tebipenem randomizing with 15 children with oral Azithromycin arm. Investigators will also check invitro susceptibility of Tebipenem-pivoxil in 200 shigella isolates prior to the clinical trial in collaboration with Infectious Diseases Division, icddr,b. Outcome measures/variables: - Clinical and microbiologic success as defined by the absence of both clinical and microbiologic failure at Day 7 - Clinical failure of test drugs as defined by the presence of fever (axillary temperature ≥38°C), diarrhoea (3 or more abnormally loose or watery stools in the last 24 hours), or blood in stool, at Day 7 of follow-up or a death prior to Day 7 - Microbiological failure as defined by the presence of Shigella in culture or Shigella DNA at quantities equal to or higher than enrolment values or Shigella isolated by microbiologic culture at Day 7.

NCT ID: NCT05108467 Recruiting - Clinical trials for Lactate Blood Increase

Saving Lives by Early Detection and Treatment of Sepsis and Septic Shock by Point of Care Lactate Test in Adults

POCLactate
Start date: October 21, 2021
Phase:
Study type: Observational

Burden: The global burden of sepsis is difficult to ascertain, although a recent scientific publication estimated that in 2017 there were 48.9 million cases and 11 million sepsis-related deaths worldwide, which accounted for almost 20% of all global deaths. Recent chart analysis from Dhaka Hospital, icddrb recorded 350 adults with severe sepsis admitted over four years. Among them, 69% of patients progressed to septic shock. Knowledge gap: Clinical features of shock due to sepsis and shock due to severe dehydration are very intertwining and often predicament for critical care physicians. If not recognized early and managed promptly, it can lead to septic shock, multiple organ failure, and eventually death. Serum lactate may play a role as the point of care test in differentiating shock due to severe sepsis from shock due to severe dehydration. Relevance: Being the largest diarrhoeal disease hospital, the Dhaka Hospital of icddr,b is ideal for researching shock with diarrheal diseases. Even though the onset of sepsis can be acute and poses a short-term mortality burden, it can also cause significant long-term morbidity, requiring treatment and support. Thus, addressing sepsis and severe sepsis by early detection and prompt management should be a comprehensive way to reduce the burden in our community.