Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06613997
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
21-day Double-blind Trial of Albendazole in Adults With Loa Loa Microfilaremia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Randomized Double-blind Trial Evaluating the Safety and Efficacy of a 21-day Course of Albendazole 400mgDay in Subjects With High Loa Loa Microfilaremia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STOP-FiLAR-ALB
Brief Summary:
Our aim is to test the hypothesis that a 3-week course of albendazole 400 mg daily is safe and can progressively reduce Loa loa microfilarial densities in subjects with microfilaremia
Detailed Description:
Onchocerciasis a parasitic disease caused by Onchocerca volvulus present in sub-Saharan Africa is subject of control programs based on the massive annual administration of ivermectin to the entire population living in endemic zones without prior diagnosis These programs are hampered in certain regions areas coendemic with loasis due to the Loa loa parasite due to the risk of serious adverse effects caused by ivermectin in individuals heavily infected The aim of this research is to evaluate an albendazole-based pre-treatment strategy to reduce the microfilarial density of loasis enabling the safe use of ivermectin in all areas affected by onchocerciasis
The efficacy of albendazole in reducing Loa loa microfilarial densities was evaluated in less than 100 individuals in 3 clinical trials A 3-day regimen of ALB 200 mg daily showed no effect on Loa loa microfilarial densities A single dose of 800 mg every two months for one year induced a significant but insufficient reduction in Loa loa microfilarial densities to eliminate the risk of post-ivermectin side effects The most interesting results came from a trial involving 21 subjects 10 in the albendazole group and 11 in the placebo group twice-daily treatment with 200 mg ALB for 21 days progressively reduced Loa loa microfilarial densities by 80 over six months However the geometric mean of Loa loa microfilarial densities and the highest Loa loa microfilarial density in the albendazole group were 2369 and 20200 mfmL respectively ie below the risk threshold for serious adverse effects
This project is based on a double-blind randomized placebo-controlled clinical trial It aims to evaluate the safety and efficacy of 21 days of albendazole in Loa loa microfilaremia patients The trial will be conducted in a rural area of Congo Niari department Mossendjo district and Lékoumou department Komono district A total of 100 subjects will be included in the study Participants will receive either albendazole 400 mg daily or a similar placebo for 21 days The aim is to recruit as many individuals as possible with at least 20000 mfsmL during the screening campaign but we will be able to include all patients with microfilaremia The individuals included will be monitored for 6 months 50 days of close follow-up for safety and 180 days of follow-up for efficacy Initially the majority of analyses will be descriptive An Intention-to-Treat analysis will be performed A Per Protocol analysis will be performed in the event of protocol deviations The main evaluation criteria will be
Tolerance of a 21-day course of albendazole 400mgday in L loa-infected individuals with mfs in the bloodstream criterion no serious adverse events occurred in the albendazole-treated group
Efficacy describe the kinetics of L loa microfilarial densities measured at 2 7 15 22 30 90 and 180 days post-treatment and the percentage of individuals who reduced their microfilarial load by at least 30 of their initial value
The study will implement rigorous ethical procedures to ensure the safety and well-being of participants The main objective is to minimize risks and maximize potential public health benefits The study will comply with all applicable local laws regulations and ethical guidelines including the Declaration of Helsinki and Good Clinical Practice and will be preceded by full information given to participants Free and informed consent will be obtained and participation will be voluntary Risks include mild discomfort during the fingertip prick required for microfilaremia monitoring and possible mild side effects associated with albendazole On the other hand benefits include the possibility of free medical screening and a contribution to medical research Medical follow-up is planned to manage potential side effects The research will be carried out in suitable secure facilities located close to the participating villages for assistance in the event of an emergency A data anonymization system will be put in place to protect participants Data will be secured on a server and exchanged securely An Independent Monitoring Committee will oversee the study to guarantee the safety and interests of participants Finally specific insurance will cover participants in the event of study-related harm ensuring adequate protection in the event of complications
If successful this project could revolutionize onchocerciasis control in areas coendemic with loasis The proposed pre-treatment strategy could enable ivermectin to be administered safely helping to speed up the elimination of onchocerciasis In addition this project could have important implications for the individual treatment of subjects with high Loa loa microfilarial density offering an alternative to currently complicated and ineffective treatments
The efficacy of albendazole in reducing Loa loa microfilarial densities was evaluated in less than 100 individuals in 3 clinical trials A 3-day regimen of ALB 200 mg daily showed no effect on Loa loa microfilarial densities A single dose of 800 mg every two months for one year induced a significant but insufficient reduction in Loa loa microfilarial densities to eliminate the risk of post-ivermectin side effects The most interesting results came from a trial involving 21 subjects 10 in the albendazole group and 11 in the placebo group twice-daily treatment with 200 mg ALB for 21 days progressively reduced Loa loa microfilarial densities by 80 over six months However the geometric mean of Loa loa microfilarial densities and the highest Loa loa microfilarial density in the albendazole group were 2369 and 20200 mfmL respectively ie below the risk threshold for serious adverse effects
This project is based on a double-blind randomized placebo-controlled clinical trial It aims to evaluate the safety and efficacy of 21 days of albendazole in Loa loa microfilaremia patients The trial will be conducted in a rural area of Congo Niari department Mossendjo district and Lékoumou department Komono district A total of 100 subjects will be included in the study Participants will receive either albendazole 400 mg daily or a similar placebo for 21 days The aim is to recruit as many individuals as possible with at least 20000 mfsmL during the screening campaign but we will be able to include all patients with microfilaremia The individuals included will be monitored for 6 months 50 days of close follow-up for safety and 180 days of follow-up for efficacy Initially the majority of analyses will be descriptive An Intention-to-Treat analysis will be performed A Per Protocol analysis will be performed in the event of protocol deviations The main evaluation criteria will be
Tolerance of a 21-day course of albendazole 400mgday in L loa-infected individuals with mfs in the bloodstream criterion no serious adverse events occurred in the albendazole-treated group
Efficacy describe the kinetics of L loa microfilarial densities measured at 2 7 15 22 30 90 and 180 days post-treatment and the percentage of individuals who reduced their microfilarial load by at least 30 of their initial value
The study will implement rigorous ethical procedures to ensure the safety and well-being of participants The main objective is to minimize risks and maximize potential public health benefits The study will comply with all applicable local laws regulations and ethical guidelines including the Declaration of Helsinki and Good Clinical Practice and will be preceded by full information given to participants Free and informed consent will be obtained and participation will be voluntary Risks include mild discomfort during the fingertip prick required for microfilaremia monitoring and possible mild side effects associated with albendazole On the other hand benefits include the possibility of free medical screening and a contribution to medical research Medical follow-up is planned to manage potential side effects The research will be carried out in suitable secure facilities located close to the participating villages for assistance in the event of an emergency A data anonymization system will be put in place to protect participants Data will be secured on a server and exchanged securely An Independent Monitoring Committee will oversee the study to guarantee the safety and interests of participants Finally specific insurance will cover participants in the event of study-related harm ensuring adequate protection in the event of complications
If successful this project could revolutionize onchocerciasis control in areas coendemic with loasis The proposed pre-treatment strategy could enable ivermectin to be administered safely helping to speed up the elimination of onchocerciasis In addition this project could have important implications for the individual treatment of subjects with high Loa loa microfilarial density offering an alternative to currently complicated and ineffective treatments
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None