Full list of author information is available at the end of the articletolerability of both drugs ... more Full list of author information is available at the end of the articletolerability of both drugs were assessed by caregiver questionnaire.
The Malaysian Journal of Medical Sciences : MJMS, 2021
Background Hepatitis A and B causes morbidity and mortality among patients. This study determined... more Background Hepatitis A and B causes morbidity and mortality among patients. This study determined the proportion of hepatitis A, B viruses (HAV, HBV) and genetic diversity of HBV among jaundice patients at the Coast General Hospital, Mombasa County, Kenya. Methods A cross-sectional study was conducted among 222 patients; recruited and screened for hepatitis B surface antigen (HBsAg) and anti-HAV IgM. Viral deoxyribonucleic acid (DNA) was extracted from positive samples; partial hepatitis B virus-pol (HBV-pol) gene amplified, directly sequenced and generated sequences phylogenetically analysed using MEGA X software. Demographic characteristics were compared in relation to HBV infection using Chi-square. Results Forty-seven (21.2%) out of the 222 patients tested positive for HBV while no HAV was detected. Among those infected, n = 8 (3.6%) were females and n = 39 (17.6%) males. Forty-five samples amplified and sequenced successfully. However, two samples failed to amplify. Phylogeneti...
Objectives: Hepatitis B virus (HBV) infection and emergence of drug resistance have remained one ... more Objectives: Hepatitis B virus (HBV) infection and emergence of drug resistance have remained one of the major public health puzzles. This study determined circulating HBV genotypes and nucleoside analog resistance to provide information in choosing the best therapy. Methods: A cross-sectional study was conducted among jaundiced patients visiting Coast General Teaching and Referral Hospital during the period between February and August 2018. A total of 222 patients were recruited and screened for HBsAg following the ethical procedure. Viral DNA was extracted from positive samples, partial HBV-pol gene amplified, and directly sequenced and analyzed using web-based software prediction to genotypic resistance mutations. Results: Forty-seven (21.2%) of the 222 patients tested positive for HBV. Of the 45 samples successfully sequenced, 12 (26.4%) had drug resistance. Six patients (13.3%) had rtV173L, rtL180M, and rtM204V mutations; five subjects (11.1%) with rtL180M and rtM204V while 1 pa...
Background Governments, universities and pan-African research networks are building durable infra... more Background Governments, universities and pan-African research networks are building durable infrastructure and capabilities for biomedical research in Africa. This offers the opportunity to adopt from the outset innovative approaches and technologies that would be challenging to retrofit into fully established research infrastructures such as those regularly found in high-income countries. In this context we piloted the use of a novel mobile digital health platform, designed specifically for low-resource environments, to support high-quality data collection in a clinical research study. Objective Our primary aim was to assess the feasibility of a using a mobile digital platform for clinical trial data collection in a low-resource setting. Secondarily, we sought to explore the potential benefits of such an approach. Methods The investigative site was a research institute in Nairobi, Kenya. We integrated an open-source platform for mobile data collection commonly used in the developing world with an open-source, standard platform for electronic data capture in clinical trials. The integration was developed using common data standards (Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model), maximising the potential to extend the approach to other platforms. The system was deployed in a pharmacokinetic study involving healthy human volunteers. Results The electronic data collection platform successfully supported conduct of the study. Multidisciplinary users reported high levels of satisfaction with the mobile application and highlighted substantial advantages when compared with traditional paper record systems. The new system also demonstrated a potential for expediting data quality review. Discussion and Conclusions This pilot study demonstrated the feasibility of using a mobile digital platform for clinical research data collection in low-resource settings. Sustainable scientific capabilities and infrastructure are essential to attract and support clinical research studies. Since many research structures in Africa are being developed anew, stakeholders should consider implementing innovative technologies and approaches.
Clinical pharmacology and therapeutics, Jan 5, 2017
A strong scientific rationale exists for conducting clinical pharmacology studies in target popul... more A strong scientific rationale exists for conducting clinical pharmacology studies in target populations because local factors such as genetics, environment, comorbidities, and diet can affect variability in drug responses. However, clinical pharmacology studies are not widely conducted in sub-Saharan Africa, in part due to limitations in technical expertise and infrastructure. Since 2012, a novel public-private partnership model involving research institutions and a pharmaceutical company has been applied to developing increased capability for clinical pharmacology research in multiple African countries.
Background WHO recommends combinations of an artemisinin derivative plus an antimalarial drug of ... more Background WHO recommends combinations of an artemisinin derivative plus an antimalarial drug of longer half-life as treatment options for uncomplicated Plasmodium falciparum infection. In Africa, artemether-lumefantrine is the most widely used artemisinin-based combination therapy, whereas artesunate-mefl oquine is used infrequently because of a perceived poor tolerance to mefl oquine. WHO recommends reconsideration of the use of artesunatemefl oquine in Africa. We compared the effi cacy and safety of fi xed-dose artesunate-mefl oquine with that of artemetherlumefantrine for treatment of children younger than 5 years with uncomplicated P falciparum malaria. Methods We did this multicentre, phase 4, open-label, non-inferiority trial in Burkina Faso, Kenya, and Tanzania. Children aged 6-59 months with uncomplicated malaria were randomly assigned (1:1), via a computer-generated randomisation list, to receive 3 days' treatment with either one or two artesunate-mefl oquine tablets (25 mg artesunate and 55 mg mefl oquine) once a day or one or two artemether-lumefantrine tablets (20 mg artemether and 120 mg lumefantrine) twice a day. Parasitological assessments were done independently by two microscopists who were blinded to treatment allocation. The primary outcome was the PCR-corrected rate of adequate clinical and parasitological response (ACPR) at day 63 in the per-protocol population. Non-inferiority was shown if the lower limit of the 95% CI for the diff erence between groups was greater than-5%. Early vomiting was monitored and neuropsychiatric status assessed regularly during follow-up. This study is registered with ISRCTN, number ISRCTN17472707, and the Pan African Clinical Trials Registry, number PACTR201202000278282. Findings 945 children were enrolled and randomised, 473 to artesunate-mefl oquine and 472 to artemetherlumefantrine. The per-protocol population consisted of 407 children in each group. The PCR-corrected ACPR rate at day 63 was 90•9% (370 patients) in the artesunate-mefl oquine group and 89•7% (365 patients) in the artemetherlumefantrine group (treatment diff erence 1•23%, 95% CI-2•84% to 5•29%). At 72 h after the start of treatment, no child had detectable parasitaemia and less than 6% had fever, with a similar number in each group (21 in the artesunate-mefl oquine group vs 24 in the artemether-lumefantrine group). The safety profi les of artesunatemefl oquine and artemether-lumefantrine were similar, with low rates of early vomiting (71 [15•3%] of 463 patients in the artesunate-mefl oquine group vs 79 [16•8%] of 471 patients in the artemether-lumefantrine group in any of the three dosing days), few neurological adverse events (ten [2•1%] of 468 vs fi ve [1•1%] of 465), and no detectable psychiatric adverse events. Interpretation Artesunate-mefl oquine is eff ective and safe, and an important treatment option, for children younger than 5 years with uncomplicated P falciparum malaria in Africa.
Full list of author information is available at the end of the articletolerability of both drugs ... more Full list of author information is available at the end of the articletolerability of both drugs were assessed by caregiver questionnaire.
The Malaysian Journal of Medical Sciences : MJMS, 2021
Background Hepatitis A and B causes morbidity and mortality among patients. This study determined... more Background Hepatitis A and B causes morbidity and mortality among patients. This study determined the proportion of hepatitis A, B viruses (HAV, HBV) and genetic diversity of HBV among jaundice patients at the Coast General Hospital, Mombasa County, Kenya. Methods A cross-sectional study was conducted among 222 patients; recruited and screened for hepatitis B surface antigen (HBsAg) and anti-HAV IgM. Viral deoxyribonucleic acid (DNA) was extracted from positive samples; partial hepatitis B virus-pol (HBV-pol) gene amplified, directly sequenced and generated sequences phylogenetically analysed using MEGA X software. Demographic characteristics were compared in relation to HBV infection using Chi-square. Results Forty-seven (21.2%) out of the 222 patients tested positive for HBV while no HAV was detected. Among those infected, n = 8 (3.6%) were females and n = 39 (17.6%) males. Forty-five samples amplified and sequenced successfully. However, two samples failed to amplify. Phylogeneti...
Objectives: Hepatitis B virus (HBV) infection and emergence of drug resistance have remained one ... more Objectives: Hepatitis B virus (HBV) infection and emergence of drug resistance have remained one of the major public health puzzles. This study determined circulating HBV genotypes and nucleoside analog resistance to provide information in choosing the best therapy. Methods: A cross-sectional study was conducted among jaundiced patients visiting Coast General Teaching and Referral Hospital during the period between February and August 2018. A total of 222 patients were recruited and screened for HBsAg following the ethical procedure. Viral DNA was extracted from positive samples, partial HBV-pol gene amplified, and directly sequenced and analyzed using web-based software prediction to genotypic resistance mutations. Results: Forty-seven (21.2%) of the 222 patients tested positive for HBV. Of the 45 samples successfully sequenced, 12 (26.4%) had drug resistance. Six patients (13.3%) had rtV173L, rtL180M, and rtM204V mutations; five subjects (11.1%) with rtL180M and rtM204V while 1 pa...
Background Governments, universities and pan-African research networks are building durable infra... more Background Governments, universities and pan-African research networks are building durable infrastructure and capabilities for biomedical research in Africa. This offers the opportunity to adopt from the outset innovative approaches and technologies that would be challenging to retrofit into fully established research infrastructures such as those regularly found in high-income countries. In this context we piloted the use of a novel mobile digital health platform, designed specifically for low-resource environments, to support high-quality data collection in a clinical research study. Objective Our primary aim was to assess the feasibility of a using a mobile digital platform for clinical trial data collection in a low-resource setting. Secondarily, we sought to explore the potential benefits of such an approach. Methods The investigative site was a research institute in Nairobi, Kenya. We integrated an open-source platform for mobile data collection commonly used in the developing world with an open-source, standard platform for electronic data capture in clinical trials. The integration was developed using common data standards (Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model), maximising the potential to extend the approach to other platforms. The system was deployed in a pharmacokinetic study involving healthy human volunteers. Results The electronic data collection platform successfully supported conduct of the study. Multidisciplinary users reported high levels of satisfaction with the mobile application and highlighted substantial advantages when compared with traditional paper record systems. The new system also demonstrated a potential for expediting data quality review. Discussion and Conclusions This pilot study demonstrated the feasibility of using a mobile digital platform for clinical research data collection in low-resource settings. Sustainable scientific capabilities and infrastructure are essential to attract and support clinical research studies. Since many research structures in Africa are being developed anew, stakeholders should consider implementing innovative technologies and approaches.
Clinical pharmacology and therapeutics, Jan 5, 2017
A strong scientific rationale exists for conducting clinical pharmacology studies in target popul... more A strong scientific rationale exists for conducting clinical pharmacology studies in target populations because local factors such as genetics, environment, comorbidities, and diet can affect variability in drug responses. However, clinical pharmacology studies are not widely conducted in sub-Saharan Africa, in part due to limitations in technical expertise and infrastructure. Since 2012, a novel public-private partnership model involving research institutions and a pharmaceutical company has been applied to developing increased capability for clinical pharmacology research in multiple African countries.
Background WHO recommends combinations of an artemisinin derivative plus an antimalarial drug of ... more Background WHO recommends combinations of an artemisinin derivative plus an antimalarial drug of longer half-life as treatment options for uncomplicated Plasmodium falciparum infection. In Africa, artemether-lumefantrine is the most widely used artemisinin-based combination therapy, whereas artesunate-mefl oquine is used infrequently because of a perceived poor tolerance to mefl oquine. WHO recommends reconsideration of the use of artesunatemefl oquine in Africa. We compared the effi cacy and safety of fi xed-dose artesunate-mefl oquine with that of artemetherlumefantrine for treatment of children younger than 5 years with uncomplicated P falciparum malaria. Methods We did this multicentre, phase 4, open-label, non-inferiority trial in Burkina Faso, Kenya, and Tanzania. Children aged 6-59 months with uncomplicated malaria were randomly assigned (1:1), via a computer-generated randomisation list, to receive 3 days' treatment with either one or two artesunate-mefl oquine tablets (25 mg artesunate and 55 mg mefl oquine) once a day or one or two artemether-lumefantrine tablets (20 mg artemether and 120 mg lumefantrine) twice a day. Parasitological assessments were done independently by two microscopists who were blinded to treatment allocation. The primary outcome was the PCR-corrected rate of adequate clinical and parasitological response (ACPR) at day 63 in the per-protocol population. Non-inferiority was shown if the lower limit of the 95% CI for the diff erence between groups was greater than-5%. Early vomiting was monitored and neuropsychiatric status assessed regularly during follow-up. This study is registered with ISRCTN, number ISRCTN17472707, and the Pan African Clinical Trials Registry, number PACTR201202000278282. Findings 945 children were enrolled and randomised, 473 to artesunate-mefl oquine and 472 to artemetherlumefantrine. The per-protocol population consisted of 407 children in each group. The PCR-corrected ACPR rate at day 63 was 90•9% (370 patients) in the artesunate-mefl oquine group and 89•7% (365 patients) in the artemetherlumefantrine group (treatment diff erence 1•23%, 95% CI-2•84% to 5•29%). At 72 h after the start of treatment, no child had detectable parasitaemia and less than 6% had fever, with a similar number in each group (21 in the artesunate-mefl oquine group vs 24 in the artemether-lumefantrine group). The safety profi les of artesunatemefl oquine and artemether-lumefantrine were similar, with low rates of early vomiting (71 [15•3%] of 463 patients in the artesunate-mefl oquine group vs 79 [16•8%] of 471 patients in the artemether-lumefantrine group in any of the three dosing days), few neurological adverse events (ten [2•1%] of 468 vs fi ve [1•1%] of 465), and no detectable psychiatric adverse events. Interpretation Artesunate-mefl oquine is eff ective and safe, and an important treatment option, for children younger than 5 years with uncomplicated P falciparum malaria in Africa.
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