Conference Material > Poster
Cazes C, Phelan KPQ, Hubert V, Boubacar H, Tshibangu G, et al.
MSF Scientific Days International 2021: Research. 18 May 2021
Journal Article > ResearchFull Text
Am J Trop Med Hyg. 10 October 2016; Volume 95 (Issue 6); DOI:10.4269/ajtmh.16-0026
Loubet P, Palich R, Kojan R, Peyrouset O, Danel C, et al.
Am J Trop Med Hyg. 10 October 2016; Volume 95 (Issue 6); DOI:10.4269/ajtmh.16-0026
The 2014 Ebola epidemic has shown the importance of accurate and rapid triage tools for patients with suspected Ebola virus disease (EVD). Our objective was to create a predictive score for EVD. We retrospectively reviewed all suspected cases admitted to the Ebola treatment center (ETC) in Nzérékoré, Guinea, between December 2, 2014, and February 23, 2015. We used a multivariate logistic regression model to identify clinical and epidemiological factors associated with EVD, which were used to create a predictive score. A bootstrap sampling method was applied to our sample to determine characteristics of the score to discriminate EVD. Among the 145 patients included in the study (48% male, median age 29 years), EVD was confirmed in 76 (52%) patients. One hundred and eleven (77%) patients had at least one epidemiological risk factor. Optimal cutoff value of fever to discriminate EVD was 38.5°C. After adjustment on presence of a risk factor, temperature higher than 38.5°C (odds ratio [OR] = 18.1, 95% confidence interval [CI] = 7.6-42.9), and anorexia (OR = 2.5, 95% CI = 1.1-6.1) were independently associated with EVD. The score had an area under curve of 0.85 (95% CI = 0.78-0.91) for the prediction of laboratory-confirmed EVD. Classification of patients in a high-risk group according to the score had a lower sensitivity (71% versus 86%) but higher specificity (85% versus 41%) than the existing World Health Organization algorithm. This score, which requires external validation, may be used in high-prevalence settings to identify different levels of risk in EVD suspected patients and thus allow a better orientation in different wards of ETC.
Journal Article > ResearchFull Text
PLOS Med. 1 March 2016; Volume 13 (Issue 3); DOI:10.1371/journal.pmed.1001967
Sissoko D, Laouenan C, Folkesson E, M’Lebing A, Beavogui A, et al.
PLOS Med. 1 March 2016; Volume 13 (Issue 3); DOI:10.1371/journal.pmed.1001967
Ebola virus disease (EVD) is a highly lethal condition for which no specific treatment has proven efficacy. In September 2014, while the Ebola outbreak was at its peak, the World Health Organization released a short list of drugs suitable for EVD research. Favipiravir, an antiviral developed for the treatment of severe influenza, was one of these. In late 2014, the conditions for starting a randomized Ebola trial were not fulfilled for two reasons. One was the perception that, given the high number of patients presenting simultaneously and the very high mortality rate of the disease, it was ethically unacceptable to allocate patients from within the same family or village to receive or not receive an experimental drug, using a randomization process impossible to understand by very sick patients. The other was that, in the context of rumors and distrust of Ebola treatment centers, using a randomized design at the outset might lead even more patients to refuse to seek care. Therefore, we chose to conduct a multicenter non-randomized trial, in which all patients would receive favipiravir along with standardized care. The objectives of the trial were to test the feasibility and acceptability of an emergency trial in the context of a large Ebola outbreak, and to collect data on the safety and effectiveness of favipiravir in reducing mortality and viral load in patients with EVD. The trial was not aimed at directly informing future guidelines on Ebola treatment but at quickly gathering standardized preliminary data to optimize the design of future studies.
Conference Material > Abstract
Cazes C, Phelan KPQ, Hubert V, Boubacar H, Bozama LI, et al.
MSF Scientific Days International 2021: Research. 19 May 2021
INTRODUCTION
The Optimising MAlnutrition treatment (OptiMA) strategy aims to simplify current malnutrition treatment protocols for children with mid-upper arm circumference (MUAC)<125mm or oedema, by supplementing with one product—ready-to-use therapeutic food (RUTF), using gradually reducing doses as a child’s weight and MUAC increases.
METHODS
This non-inferiority, randomized controlled trial was conducted in Kasai province, Democratic Republic of Congo (DRC). It compared the OptiMA strategy with the effective standard DRC protocol, using increasing weight doses of RUTF for treating severe acute malnutrition (SAM) and ready to use supplementary food (RUSF) at fixed dose for moderate acute malnutrition. Children aged 6–59 months with MUAC<125mm or weight-for-height Z score<−3 or oedema, and without medical complications, were randomized to either OptiMA or the standard protocol, and followed up for six months. Primary outcome was a composite indicator at 6 months’ follow-up: child alive, not acutely malnourished per the study definition, and without any additional episode of acute malnutrition throughout the observation period. Non-inferiority was determined if the upper boundary of the 95% confidence interval (CI) for the difference between randomized arms in the proportion of children with favourable outcome was less than 10%, for both intention-to-treat (ITT) and per-protocol (PP) analyses. Superiority was determined if the upper boundary of the 95% CI for this difference was lower than 0%.
ETHICS
This study was approved by the National Congolese Health Ethics Committee and by the Ethics Evaluation Committee of Inserm, the French National Institute for Health and Medical Research. ClinicalTrials.gov number, NCT03751475.
RESULTS
Between July 2019 and July 2020, 981 children were enrolled. 896 children were included in ITT analysis, with 450 in the OptiMA arm and 446 standard; 792 were included in PP analysis. Over the entire follow-up, 450 (100%) children under OptiMA received RUTF treatment while under the standard protocol, 315 (71%) received RUTF or RUSF or both. ITT analysis found that 325 (72.2%) children had favourable outcome under OptiMA versus 282 (63.2%) in the standard arm (difference: -9.2%, 95%CI -15.9% to -2.0%). Under OptiMA, weight gain was greater (median weight gain, 1700g versus 1600g, p= 0.003), the nutritional treatment consumption lower (median of 64 of RUTF versus 102 sachets of RUTF/RUSF under standard; p= 0.018). Median time to recovery (i.e., MUAC>124mm without oedema for two consecutive visits) was lower under OptiMA than under standard: 5 weeks (95%CI 5–5) versus 9 weeks (95%CI 8–10), p<0.001. We did not observe a difference in hospitalization rates (10% OptiMA, 7% standard, p=0.228) or mortality rates (0.2% in both arms).
CONCLUSION
OptiMA led to better anthropometric status over a six-month period and expanded access to treatment, whilst the standard protocol partially addressed global acute malnutrition with higher consumption of nutritional products used in the trial. Our findings suggest it may be beneficial to address global acute malnutrition in one program using one product at a gradually adjusted dose.
CONFLICTS OF INTEREST
None declared.
The Optimising MAlnutrition treatment (OptiMA) strategy aims to simplify current malnutrition treatment protocols for children with mid-upper arm circumference (MUAC)<125mm or oedema, by supplementing with one product—ready-to-use therapeutic food (RUTF), using gradually reducing doses as a child’s weight and MUAC increases.
METHODS
This non-inferiority, randomized controlled trial was conducted in Kasai province, Democratic Republic of Congo (DRC). It compared the OptiMA strategy with the effective standard DRC protocol, using increasing weight doses of RUTF for treating severe acute malnutrition (SAM) and ready to use supplementary food (RUSF) at fixed dose for moderate acute malnutrition. Children aged 6–59 months with MUAC<125mm or weight-for-height Z score<−3 or oedema, and without medical complications, were randomized to either OptiMA or the standard protocol, and followed up for six months. Primary outcome was a composite indicator at 6 months’ follow-up: child alive, not acutely malnourished per the study definition, and without any additional episode of acute malnutrition throughout the observation period. Non-inferiority was determined if the upper boundary of the 95% confidence interval (CI) for the difference between randomized arms in the proportion of children with favourable outcome was less than 10%, for both intention-to-treat (ITT) and per-protocol (PP) analyses. Superiority was determined if the upper boundary of the 95% CI for this difference was lower than 0%.
ETHICS
This study was approved by the National Congolese Health Ethics Committee and by the Ethics Evaluation Committee of Inserm, the French National Institute for Health and Medical Research. ClinicalTrials.gov number, NCT03751475.
RESULTS
Between July 2019 and July 2020, 981 children were enrolled. 896 children were included in ITT analysis, with 450 in the OptiMA arm and 446 standard; 792 were included in PP analysis. Over the entire follow-up, 450 (100%) children under OptiMA received RUTF treatment while under the standard protocol, 315 (71%) received RUTF or RUSF or both. ITT analysis found that 325 (72.2%) children had favourable outcome under OptiMA versus 282 (63.2%) in the standard arm (difference: -9.2%, 95%CI -15.9% to -2.0%). Under OptiMA, weight gain was greater (median weight gain, 1700g versus 1600g, p= 0.003), the nutritional treatment consumption lower (median of 64 of RUTF versus 102 sachets of RUTF/RUSF under standard; p= 0.018). Median time to recovery (i.e., MUAC>124mm without oedema for two consecutive visits) was lower under OptiMA than under standard: 5 weeks (95%CI 5–5) versus 9 weeks (95%CI 8–10), p<0.001. We did not observe a difference in hospitalization rates (10% OptiMA, 7% standard, p=0.228) or mortality rates (0.2% in both arms).
CONCLUSION
OptiMA led to better anthropometric status over a six-month period and expanded access to treatment, whilst the standard protocol partially addressed global acute malnutrition with higher consumption of nutritional products used in the trial. Our findings suggest it may be beneficial to address global acute malnutrition in one program using one product at a gradually adjusted dose.
CONFLICTS OF INTEREST
None declared.
Conference Material > Poster
Cazes C, Phelan KPQ, Hubert V, Boubacar H, Tshibangu G, et al.
MSF Scientific Days International 2021: Research. 18 May 2021
Conference Material > Slide Presentation
Cazes C, Phelan KPQ, Hubert V, Boubacar H, Bozama LI, et al.
MSF Scientific Days International 2021: Research. 19 May 2021