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NCT ID: NCT04829630 Not yet recruiting - Rabies Clinical Trials

Immunity Persistence After Abridged Intradermal Rabies PEP

RESIST-3
Start date: May 2021
Phase: N/A
Study type: Interventional

After exposure, rabies can be prevented in almost 100% of cases by the administration of sufficient and timely post-exposure prophylaxis (PEP). PEP is based on wound cleansing, antisepsis, administration of rabies vaccine as well as rabies immunoglobulin, if reviewed. However, anti-rabies PEP remains too often out of financial and / or geographic access, especially for poor and / or rural populations in endemic countries who remain the most exposed to the risk of contracting rabies. Two major studies planned in Cambodia between 2014 and 2018 - the RESIST 0/1 clinical - epidemiological study and the RESIST-2 study on the antibody response to the vaccine - provided the basis that allowed a change in international recommendations on PPE. Since April 2018, the new "IPC protocol" of three sessions of reduced double doses (0.1 mL x 2) administered intradermally (ID) over one week has replaced the already very effective "TRC protocol" of four sessions over one month which was the reference dose-sparing protocol for endemic countries until 2018. It remains to be determined whether the IPC protocol (3 sessions / 1 week) confers long-term immunity equivalent to that obtained after a TRC ID protocol (4 sessions / 1 month). This question is of importance to public health decision-makers and clinical teams in endemic countries who would hesitate to switch to the abbreviated IPC protocol.

NCT ID: NCT04738812 Not yet recruiting - Tuberculosis Clinical Trials

Determination of Adequate Tuberculosis Regimen in Patients Hospitalized With HIV-associated Severe Immune Suppression

DATURA
Start date: September 2021
Phase: Phase 3
Study type: Interventional

DATURA trial is a phase III, multicenter, two-arm, open-label, randomized superiority trial to compare the efficacy and the safety of an intensified tuberculosis (TB) regimen versus standard TB treatment in HIV-infected adults and adolescents hospitalized for TB with CD4 ≤ 100 cells/μL over 48 weeks: - Intensified TB treatment regimen: increased doses of rifampicin and isoniazid together with standard-dose of pyrazinamide and ethambutol for 8 weeks in addition to prednisone for 6 weeks and albendazole for 3 days - WHO standard TB treatment regimen. The continuation phase of TB treatment will be identical in the two arms: 4 months of rifampicin and isoniazid at standard doses.

NCT ID: NCT04706130 Not yet recruiting - Vivax Malaria Clinical Trials

Rigorous Assessment of P. Vivax Relapses and Primaquine Efficacy for Radical Cure

Start date: February 2021
Phase: N/A
Study type: Interventional

The study will be an open-labelled randomized clinical trial to determine therapeutic efficacy. Note that this will not be an Investigational New Drug application, as only WHO-approved drugs will be used at dosage and for conditions approved. Eligible patients willing to participate will first be tested prior to enrolment for their G6PD status by the gold standard spectrophotometric analysis. The investigators will exclude from the study any G6PD deficient (or intermediate females) patient. Treatment allocation will be randomized between i) 7 days of artesunate (2 mg/kg/day for 7 days) alone (Arm1), ii) same artesunate regimen + 0.25 mg/kg/day 14 days of primaquine (Arm2) and iii) same artesunate regimen + 0.5 mg/kg/day 14 days of primaquine (Arm3). All patients will be relocated to a no-transmission city (Chbar Mon) to make sure they are not reinfected during the follow-up. Follow-up will be performed every 24-48h for 90 days. At the end of the follow-up period, all patients that did not receive primaquine (arm1) will be treated according to national guidelines (14 days at 0.25mg/kg/day). Patients will additionally be followed monthly for three months after the end of the relocation.

NCT ID: NCT04704999 Not yet recruiting - Clinical trials for Plasmodium Vivax Malaria

Southeast Asia Dose Optimization of Tafenoquine

SEADOT
Start date: October 1, 2021
Phase: Phase 4
Study type: Interventional

Tafenoquine was recently approved by regulatory authorities in the USA and Australia. Tafenoquine is an alternative radical curative treatment to primaquine acting against the dormant liver stage of Plasmodium vivax (the hypnozoite). Tafenoquine (an 8-aminoquinoline) has the substantial advantage of single dosing as compared to a 14-day course of primaquine to achieve radical cure. The recommended tafenoquine dose is 300 mg, which was shown to be significantly worse in radical curative efficacy to a total primaquine dose of 3.5 mg/kg in Southeast Asia. The cure rate of tafenoquine 300 mg in Southeast Asian study sites was only 74%. The comparator 3.5 mg/kg total primaquine dose is the standard and most commonly used dose globally, but in Southeast Asia and the Western Pacific, higher doses of primaquine are needed for radical cure. This study aims to determine the optimal dose of tafenoquine in Southeast Asia.

NCT ID: NCT04663620 Recruiting - Neonatal Mortality Clinical Trials

Saving Babies Lives

SBL
Start date: January 1, 2018
Phase: N/A
Study type: Interventional

The central hypothesis of this study is that a neonatal healthcare programme that has a significant impact on neonatal mortality and which spans the healthcare journey from village to referral hospital can be developed and implemented in a low-resource rural setting. This study is a five-year stepped-wedge cluster-randomised trial, covering a rural and isolated province in North-Eastern Cambodia. The intervention of this study is the Saving Babies' Lives programme, which is a comprehensive, contextual and iterative neonatal healthcare package. The Saving Babies' Lives programme comprises a training programme for primary care facilities, and participatory action research with community health workers (know in Cambodia as village health support group volunteers). The control is no intervention; standard government service continues. Qualitative and quantitative data collection supports improvements in the iterative programme, and evaluation of the study, with the intention of creating a scalable blueprint.

NCT ID: NCT04594395 Not yet recruiting - Healthy Volunteers Clinical Trials

Defining the COVID-19 Immunity Denominator in the Mekong: a Cross-Sectional Seroprevalence Study of SARS-CoV-2 in HealthyVolunteers

Start date: April 20, 2021
Phase:
Study type: Observational

Background: In early 2020, many people thought Cambodia would have a serious COVID-19 outbreak due to the high number of Chinese travelers going to Cambodia. But as of June 14, 2020, only 128 cases of COVID-19 have been identified in the country. Many of these cases have been from people who had traveled in Europe. Researchers want to do antibody tests on blood from a sampling of people in Phnom Penh to learn the infection risks for people in the greater Phnom Penh area. Objective: To estimate the level of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in the blood of people living in Phnom Penh, Cambodia. Eligibility: Healthy males and females age 18-65 living in Phnom Penh since January 2020. Design: A mobile unit will travel to schools, shopping areas, parks, and pagodas around Phnom Penh. Participants will be screened with questions about their age and where they live. They will have blood taken via fingerstick. About 80 uL of blood will be taken. It will be tested for SARS-CoV-2. This visit will take about 30 minutes. If the test result is positive, participants will be contacted by phone. They will be asked to have a second blood draw. This time, 20 mL of blood will be taken. They can have this visit at their home or in a clinic. This visit will take about 30 minutes. If a participant has an adverse event, the mobile units and at-home units will have the tools needed to aid the participant. If needed, the participant will be sent to a nearby clinic. ...

NCT ID: NCT04594122 Enrolling by invitation - Food Safety Clinical Trials

Good Hygiene Practice Interventions for Safer Pork at Traditional Markets in Cambodia

SFFF Cambodia
Start date: June 30, 2020
Phase: N/A
Study type: Interventional

Safe Food Fair Food for Cambodia (SFFF) is a Feed the Future Innovation Lab project funded by USAID. This 3-year project aims to improve food safety of animal source food (ASF) in Cambodia. SFFF was awarded to the International Livestock Research Institute (ILRI), National Animal Health and Production Research Institute (NAHPRI) and Livestock Development for Community Livelihood Organization (LDC) and in collaboration with Cambodian Ministry of Health CDC and NIPH. Based on the findings and consultations with food safety stakeholders in Cambodia, we have developed a set of interventions to improve hygienic practice and pork safety at the traditional markets in Cambodia. Those interventions will be introduced and tested at retail in six selected provinces using Randomized Controlled Trials (RCT). To ensure compliance of targeted actors (e.g. retailers), participatory methods (e.g. FGD) were used to validate intervention packages. There are two steps of intervention which contain of part 1) Retailer formative research for SFFF Cambodia and 2) Interventions for Good Hygiene Practices for Safer Pork at Traditional Markets. Part 1. Retailer formative research for SFFF Cambodia: We will implement an intervention package to this trial group and collect biological sampling to determine the hygienic status before and after the intervention. The intervention packages will be developed for SFFF Cambodia in consultation with partners and based on findings of SFFF Cambodia project. Part 2. Intervention for Good Hygiene Practices for Safer Pork at Traditional Markets: A randomized controlled trial (RCT) intervention will be conducted in 12 markets in 6 provinces. Those provinces were selected based on the prevalence of Salmonella in a market survey study, namely Kampot, Kampong Cham, Kampong Speu, Takeo, Siem Reap, and Phnom Penh. Another 12 markets, in the same provinces, will be used as a control group. In total 24 traditional wet markets will be included in the sampling, by selecting the 4 largest traditional markets in the six provinces with at least 15 pork shops. At each market, 15 pork shops were selected for sampling. The intervention package includes 5 keys actions (Handbook) and provision of equipment incentive (e.g. inox tray, easy-clean surface material), and training on good hygiene practices.

NCT ID: NCT04434846 Not yet recruiting - Dengue Fever Clinical Trials

Sylvatic Transmission and Reservoir Potential of Zika, Dengue, and Chikungunya Viruses of Co-located Humans and Long-tailed Macaques in Thailand and Cambodia

Start date: April 20, 2021
Phase:
Study type: Observational

Background: Zika, dengue, and chikungunya are spread by mosquitos. These diseases have a major impact on public health. This is especially true in in Southeast Asia. Non-human primates (such as macaques) could play an essential role in spreading these diseases. Researchers want to further understand the relationship between humans and these primates. They want to see how this affects how mosquito-borne viruses are spread in Southeast Asia. Objective: To describe the prevalence of Zika virus, dengue virus, and chikungunya virus in the blood of people who live close to long-tailed macaques in Thailand and Cambodia. Eligibility: Healthy people aged 18-55 who have lived or worked within approximately 10 kilometers of the Wat Amphae Phnom monkey habitat in Kampong Speu, Cambodia, for a minimum of 2 years Design: Participation will last 1 day. Participants will be screened in person through an interview. Their medical history will be reviewed. Participants will give information about themselves. This will include sex, age, and behaviors related to the spread of mosquito-borne disease. For example, they will be asked about the number of water containers at their home. They will be asked about recent travel. They will be asked about the extent of their contact with the macaques. Participants will give a blood sample....

NCT ID: NCT04350905 Completed - Clinical trials for Vector Borne Diseases

Characterization of Skin Immunity to Aedes Aegypti Saliva in Dengue-endemic Participants in Cambodia

Start date: October 27, 2020
Phase: Phase 1
Study type: Interventional

Background: Mosquito-borne viruses like dengue cause major illness and death worldwide, particularly in Southeast Asia. When mosquitoes deliver a virus into the skin of humans, they also leave saliva. Researchers want to learn more about skin immunity to mosquito saliva. They hope this will help with future vaccines and treatments for these diseases. Objective: To compare the early and late innate immune response in the skin of Aedes aegypti bitten versus unbitten skin. Eligibility: Healthy people ages 18-45 who live within about 15 km of the study site in Chbar Mon Design: Participants will have 3 visits. The baseline/screening visit will include: Medical and medication history Questions about participants demographic information, mosquito biting risk factors, and responses to mosquito or other insect bites Physical exam Urine sample for some participants Mosquito feeding. A feeding device will be placed on the participant s arm for up to 20 minutes. The insects will feed through a mesh on the bottom of the feeding device. Participants may be given standard treatments for any skin reactions. Blood tests Four skin biopsies taken from bitten and unbitten skin. Local anesthetic will be administered, and a small tool will be used to remove the participant s skin. Participants will have a second visit the next day. They will have a physical exam and blood tests. They will have 1 skin biopsy. Participants will have a final visit about 2 weeks later. They will have a physical exam and blood tests. During the study, participants will be asked to take measures to prevent more mosquito bites.

NCT ID: NCT04311320 Not yet recruiting - Clinical trials for Respiratory Distress Syndrome

A Low-Resource Oxygen Blender Prototype for Use in Modified Bubble CPAP Circuits

Start date: May 2021
Phase: N/A
Study type: Interventional

Purpose: Using a novel oxygen blender prototype with modified bCPAP to manage children 1 month to 5 years of age hospitalized with respiratory distress due to lower respiratory tract infection (LRTI) in low-resource settings is not associated with clinical failure within 1 hour of use. Aim: To investigate if this novel oxygen blender is safe to use among children 1 month to 5 years old hospitalized for respiratory distress from lower respiratory tract infections in a low-resource setting.