Journal Article > LetterFull Text
Lancet Global Health. 1 January 2025; Volume 13 (Issue 1); e24.; DOI: 10.1016/S2214-109X(24)00462-5
Lee JSF, Sued O, Ribeiro I, Jarvis JN, Burry J
Lancet Global Health. 1 January 2025; Volume 13 (Issue 1); e24.; DOI: 10.1016/S2214-109X(24)00462-5
Journal Article > ReviewFull Text
Lancet Global Health. 1 September 2024; Volume 12 (Issue 9); e1552-e1559.; DOI:10.1016/S2214-109X(24)00225-0
Lee JSF, Cohen RM, Khan RA, Burry J, Casas EC, et al.
Lancet Global Health. 1 September 2024; Volume 12 (Issue 9); e1552-e1559.; DOI:10.1016/S2214-109X(24)00225-0
Journal Article > ResearchFull Text
Lancet Global Health. 1 February 2023; Volume 11 (Issue 2); e296-e300.; DOI:10.1016/S2214-109X(22)00479-X
Abouyannis M, Esmail H, Hamaluba M, Ngama M, Mwangudzah H, et al.
Lancet Global Health. 1 February 2023; Volume 11 (Issue 2); e296-e300.; DOI:10.1016/S2214-109X(22)00479-X
Snakebite clinical trials have often used heterogeneous outcome measures and there is an urgent need for standardisation. A globally representative group of key stakeholders came together to reach consensus on a globally relevant set of core outcome measurements. Outcome domains and outcome measurement instruments were identified through searching the literature and a systematic review of snakebite clinical trials. Outcome domains were shortlisted by use of a questionnaire and consensus was reached among stakeholders and the patient group through facilitated discussions and voting. Five universal core outcome measures should be included in all future snakebite clinical trials-mortality, WHO disability assessment scale, patient-specific functional scale, acute allergic reaction by Brown criteria, and serum sickness by formal criteria. Additional syndrome-specific core outcome measures should be used depending on the biting species. This core outcome measurement set provides global standardisation, supports the priorities of patients and clinicians, enables meta-analysis, and is appropriate for use in low-income and middle-income settings.
Journal Article > ResearchFull Text
Med Trop Sante Int
MTSI
MTSI bulletin
MTSI magazine
MTSI-Revue
Médecine tropicale et santé internationale. Bulletin
Médecine tropicale et santé internationale. Magazine
MTSI, la revue de la Société francophone de médecine tropicale et santé internationale. 1 February 2023; Volume 3 (Issue 3); DOI:10.48327/mtsi.v3i3.2023.421
Abouyannis M, Esmail H, Hamaluba M, Ngama M, Mwangudzah H, et al.
Med Trop Sante Int
MTSI
MTSI bulletin
MTSI magazine
MTSI-Revue
Médecine tropicale et santé internationale. Bulletin
Médecine tropicale et santé internationale. Magazine
MTSI, la revue de la Société francophone de médecine tropicale et santé internationale. 1 February 2023; Volume 3 (Issue 3); DOI:10.48327/mtsi.v3i3.2023.421
English
Français
CONTEXTE
Les essais cliniques sur les morsures de serpent ont souvent utilisé des critères de décision hétérogènes qui demandent à être standardisés.
MÉTHODE
Un groupe d'acteurs clés mondialement représentatifs s'est réuni pour parvenir à un consensus sur un jeu universel de critères de décision de base. Les domaines d'intérêt et les instruments d'évaluation des critères de décision ont été identifiés à partir d'une recherche documentaire et d'un examen systématique des essais cliniques concernant les envenimations par morsure de serpent. Les domaines d'intérêt ont été présélectionnés à l'aide d'un questionnaire et un consensus a été obtenu entre le groupe d'acteurs et un groupe représentatif de patients à la suite de discussions orientées et d'un vote.
RÉSULTATS
Cinq critères de décision de base universels devraient être inclus dans tous les futurs essais cliniques sur les morsures de serpent : la mortalité, l'échelle d'évaluation du handicap de l'OMS, l'échelle fonctionnelle propre à chaque patient, la réaction allergique immédiate selon les critères de Brown et la maladie sérique en fonction de critères formels. D'autres critères de décision spécifiques aux différents syndromes observés lors des envenimations par morsure de serpent doivent être utilisés en fonction de l'espèce responsable de la morsure.
CONCLUSION
Ce jeu universel de critères de décision de base permet une standardisation mondiale, répond aux priorités des patients et des cliniciens, favorise des méta-analyses et est compatible avec une utilisation dans les pays à revenu faible ou intermédiaire.
Les essais cliniques sur les morsures de serpent ont souvent utilisé des critères de décision hétérogènes qui demandent à être standardisés.
MÉTHODE
Un groupe d'acteurs clés mondialement représentatifs s'est réuni pour parvenir à un consensus sur un jeu universel de critères de décision de base. Les domaines d'intérêt et les instruments d'évaluation des critères de décision ont été identifiés à partir d'une recherche documentaire et d'un examen systématique des essais cliniques concernant les envenimations par morsure de serpent. Les domaines d'intérêt ont été présélectionnés à l'aide d'un questionnaire et un consensus a été obtenu entre le groupe d'acteurs et un groupe représentatif de patients à la suite de discussions orientées et d'un vote.
RÉSULTATS
Cinq critères de décision de base universels devraient être inclus dans tous les futurs essais cliniques sur les morsures de serpent : la mortalité, l'échelle d'évaluation du handicap de l'OMS, l'échelle fonctionnelle propre à chaque patient, la réaction allergique immédiate selon les critères de Brown et la maladie sérique en fonction de critères formels. D'autres critères de décision spécifiques aux différents syndromes observés lors des envenimations par morsure de serpent doivent être utilisés en fonction de l'espèce responsable de la morsure.
CONCLUSION
Ce jeu universel de critères de décision de base permet une standardisation mondiale, répond aux priorités des patients et des cliniciens, favorise des méta-analyses et est compatible avec une utilisation dans les pays à revenu faible ou intermédiaire.
Journal Article > CommentaryFull Text
BMJ Glob Health. 25 October 2021; Volume 6 (Issue 10); e006913.; DOI:10.1136/bmjgh-2021-006913
Martins D, Ribeiro I, Potet J
BMJ Glob Health. 25 October 2021; Volume 6 (Issue 10); e006913.; DOI:10.1136/bmjgh-2021-006913
SUMMARY POINTS
• Despite inherent differences, Snakebite Envenoming and COVID-19 have much in common in terms of research and development (R&D) challenges and opportunities.
• Both crises require a diversified portfolio of R&D solutions, ranging from diagnostics to treatments, that can effectively work and be accessible in different resource settings.
• Collaborative clinical research and streamlined regulatory pathways are critical to accelerate these candidates in the R&D pipeline.
• Transformative progress is possible with a concerted approach that aligns strong political will, coordinated financing and the needs of the most marginalised communities.
• Despite inherent differences, Snakebite Envenoming and COVID-19 have much in common in terms of research and development (R&D) challenges and opportunities.
• Both crises require a diversified portfolio of R&D solutions, ranging from diagnostics to treatments, that can effectively work and be accessible in different resource settings.
• Collaborative clinical research and streamlined regulatory pathways are critical to accelerate these candidates in the R&D pipeline.
• Transformative progress is possible with a concerted approach that aligns strong political will, coordinated financing and the needs of the most marginalised communities.
Journal Article > CommentaryFull Text
PLoS Negl Trop Dis. 4 June 2015; Volume 9 (Issue 6); e0003697.; DOI:10.1371/journal.pntd.0003697
Porras AI, Yadon ZE, Altcheh J, Britto C, Chaves GC, et al.
PLoS Negl Trop Dis. 4 June 2015; Volume 9 (Issue 6); e0003697.; DOI:10.1371/journal.pntd.0003697
Journal Article > ResearchFull Text
Antimicrob Agents Chemother. 3 December 2018; Volume 63 (Issue 2); DOI:10.1128/AAC.01191-18
Parrado R, Ramirez JC, de la Barra A, Alonso-Vega C, Juiz N, et al.
Antimicrob Agents Chemother. 3 December 2018; Volume 63 (Issue 2); DOI:10.1128/AAC.01191-18
This work evaluated a serial blood sampling procedure to enhance the sensitivity of duplex real-time PCR (qPCR) for baseline detection and quantification of parasitic loads and post-treatment identification of failure in the context of clinical trials for treatment of chronic Chagas disease, namely DNDi-CH-E1224-001 (NCT01489228) and MSF-DNDi PCR sampling optimization study (NCT01678599). Patients from Cochabamba (N= 294), Tarija (N= 257), and Aiquile (N= 220) were enrolled. Three serial blood samples were collected at each time-point and qPCR triplicates were tested per sample. The first two samples were collected during the same day and the third one seven days later.A patient was considered PCR positive if at least one qPCR replicate was detectable. Cumulative results of multiple samples and qPCR replicates enhanced the proportion of pre-treatment sample positivity from 54.8 to 76.2%, 59.5 to 77.8%, and 73.5 to 90.2% in Cochabamba, Tarija, and Aiquile cohorts, respectively. This strategy increased the detection of treatment failure from 72.9 to 91.7%, 77.8 to 88.9%, and 42.9 to 69.1% for E1224 low, short, and high dosage regimens, respectively; and from 4.6 to 15.9% and 9.5 to 32.1% for the benznidazole arm in the DNDi-CH-E1224-001 and MSF-DNDi studies, respectively. The addition of the third blood sample and third qPCR replicate in patients with non-detectable PCR results in the first two samples, gave a small, non-statistically significant improvement in qPCR positivity. No change in clinical sensitivity was seen with a blood volume increase from 5 to 10 ml. The monitoring of patients treated with placebo in the DNDi-CH-E1224-001 trial revealed fluctuations in parasitic loads and occasional non-detectable results. In conclusion, serial sampling strategy enhanced PCR sensitivity to detecting treatment failure during follow-up and has the potential for improving recruitment capacity in Chagas disease trials, which require an initial positive qPCR result for patient admission.
Journal Article > CommentaryFull Text
PLoS Negl Trop Dis. 31 October 2013; Volume 7 (Issue 10); e2300.; DOI:10.1371/journal.pntd.0002300
Hotez PJ, Dumonteil E, Cravioto MB, Bottazzi ME, Tapia-Conyer R, et al.
PLoS Negl Trop Dis. 31 October 2013; Volume 7 (Issue 10); e2300.; DOI:10.1371/journal.pntd.0002300
Journal Article > CommentaryFull Text
Lancet Infect Dis. 18 October 2018; Volume 19 (Issue 4); DOI:10.1016/S1473-3099(18)30493-6
Loyse A, Burry J, Cohn J, Ford NP, Chiller T, et al.
Lancet Infect Dis. 18 October 2018; Volume 19 (Issue 4); DOI:10.1016/S1473-3099(18)30493-6
In 2018, WHO issued guidelines for the diagnosis, prevention, and management of HIV-related cryptococcal disease. Two strategies are recommended to reduce the high mortality associated with HIV-related cryptococcal meningitis in low-income and middle-income countries (LMICs): optimised combination therapies for confirmed meningitis cases and cryptococcal antigen screening programmes for ambulatory people living with HIV who access care. WHO's preferred therapy for the treatment of HIV-related cryptococcal meningitis in LMICs is 1 week of amphotericin B plus flucytosine, and the alternative therapy is 2 weeks of fluconazole plus flucytosine. In the ACTA trial, 1-week (short course) amphotericin B plus flucytosine resulted in a 10-week mortality of 24% (95% CI -16 to 32) and 2 weeks of fluconazole and flucytosine resulted in a 10-week mortality of 35% (95% CI -29 to 41). However, with widely used fluconazole monotherapy, mortality because of HIV-related cryptococcal meningitis is approximately 70% in many African LMIC settings. Therefore, the potential to transform the management of HIV-related cryptococcal meningitis in resource-limited settings is substantial. Sustainable access to essential medicines, including flucytosine and amphotericin B, in LMICs is paramount and the focus of this Personal View.
Journal Article > ResearchFull Text
PLOS One. 27 November 2017; Volume 12 (Issue 11); e0188550.; DOI:10.1371/journal.pone.0188550
Ramirez JC, Parrado R, Sulleiro E, de la Barra A, Rodriguez M, et al.
PLOS One. 27 November 2017; Volume 12 (Issue 11); e0188550.; DOI:10.1371/journal.pone.0188550
Real-Time PCR (qPCR) testing is recommended as both a diagnostic and outcome measurement of etiological treatment in clinical practice and clinical trials of Chagas disease (CD), but no external quality assurance (EQA) program provides performance assessment of the assays in use. We implemented an EQA system to evaluate the performance of molecular biology laboratories involved in qPCR based follow-up in clinical trials of CD. An EQA program was devised for three clinical trials of CD: the E1224 (NCT01489228), a pro-drug of ravuconazole; the Sampling Study (NCT01678599), that used benznidazole, both conducted in Bolivia; and the CHAGASAZOL (NCT01162967), that tested posaconazole, conducted in Spain. Four proficiency testing panels containing negative controls and seronegative blood samples spiked with 1, 10 and 100 parasite equivalents (par. eq.)/mL of four Trypanosoma cruzi stocks, were sent from the Core Lab in Argentina to the participating laboratories located in Bolivia and Spain. Panels were analyzed simultaneously, blinded to sample allocation, at 4-month intervals. In addition, 302 random blood samples from both trials carried out in Bolivia were sent to Core Lab for retesting analysis. The analysis of proficiency testing panels gave 100% of accordance (within laboratory agreement) and concordance (between laboratory agreement) for all T. cruzi stocks at 100 par. eq./mL; whereas their values ranged from 71 to 100% and from 62 to 100% at 1 and 10 par. eq./mL, respectively, depending on the T. cruzi stock. The results obtained after twelve months of preparation confirmed the stability of blood samples in guanidine-EDTA buffer. No significant differences were found between qPCR results from Bolivian laboratory and Core Lab for retested clinical samples. This EQA program for qPCR analysis of CD patient samples may significantly contribute to ensuring the quality of laboratory data generated in clinical trials and molecular diagnostics laboratories of CD.