Prescription of concomitant medications in patients treated with Nifurtimox Eflornithine Combination Therapy (NECT) for T.b. gambiense second stage sleeping sickness in the Democratic Republic of the Congo

Nifurtimox eflornithine combination therapy (NECT) to treat human African trypanosomiasis (HAT), commonly called sleeping sickness, was added to the World Health Organisation's (WHO) Essential Medicines List in 2009 and to the Paediatric List in 2012. NECT was further tested and documented in a phase IIIb clinical trial in the Democratic Republic of Congo (DRC) assessing the safety, effectiveness, and feasibility of implementation under field conditions (NECT-FIELD study). This trial brought a unique possibility to examine concomitant drug management.; This is a secondary analysis of the NECT-FIELD study where 629 second stage gambiense HAT patients were treated with NECT, including children and pregnant and breastfeeding women in six general reference hospitals located in two provinces. Concomitant drugs were prescribed by the local investigators as needed. Patients underwent daily evaluations, including vital signs, physical examination, and adverse event monitoring. Concomitant medication was documented from admission to discharge. Patients' clinical profiles on admission and safety profile during specific HAT treatment were similar to previously published reports. Prescribed concomitant medications administered during the hospitalization period, before, during, and immediately after NECT treatment, were mainly analgesics/antipyretics, anthelmintics, antimalarials, antiemetics, and sedatives. Use of antibiotics was reasonable and antibiotics were often prescribed to treat cellulitis and respiratory tract infections. Prevention and treatment of neurological conditions such as convulsions, loss of consciousness, and coma was used in approximately 5% of patients.; The prescription of concomitant treatments was coherent with the clinical and safety profile of the patients. However, some prescription habits would need to be adapted in the future to the evolving available pharmacopoeia. A list of minimal essential medication that should be available at no cost to patients in treatment wards is proposed to help the different actors to plan, manage, and adequately fund drug supplies for advanced HAT infected patients.; The initial study was registered at ClinicalTrials.gov, number NCT00906880

In-hospital safety in field conditions of Nifurtimox Eflornithine Combination Therapy (NECT) for T. B. Gambiense Sleeping Sickness

Trypanosoma brucei (T.b.) gambiense Human African trypanosomiasis (HAT; sleeping sickness) is a fatal disease. Until 2009, available treatments for 2(nd) stage HAT were complicated to use, expensive (eflornithine monotherapy), or toxic, and insufficiently effective in certain areas (melarsoprol). Recently, nifurtimox-eflornithine combination therapy (NECT) demonstrated good safety and efficacy in a randomised controlled trial (RCT) and was added to the World Health Organisation (WHO) essential medicines list (EML). Documentation of its safety profile in field conditions will support its wider use

Flow diagram of the multicentre NECT trial for treatment of 2^nd stage HAT.

<p>The diagram includes detailed information on excluded patients.</p

Baseline demographic, diagnostic and clinical characteristics of the patients, by centre.

<p>Baseline demographic, diagnostic and clinical characteristics of the patients, by centre.</p

Treatment compliance, length of hospitalisation and in-hospitalisation safety of NECT by sub-population of interest.

<p>HAT = Human African trypanosomiasis.</p>*<p>Calculated from day of admission to day of discharge.</p>†<p>Possibly or probably related to study drug.</p>‡<p>CTC grades 3–5.</p

Impact de la mise en place d’un réseau des soins pour la traumatologie grave dans la ville de Kinshasa, RD Congo : étude quasi-expérimentale

Contexte et objectif: Une part non négligeable de décès posttraumatiques semble évitable par une meilleure prise en charge. L’objectif de la présente étude était d’évaluer l’impact de la mise en place d’un réseau des soins sur la mortalité des patients traumatisés graves dans la ville de Kinshasa. Méthodes: C’était une étude multicentrique quasi-expérimentale avant/après portant sur les patients adultes hospitalisés en réanimation ousoins intensifs pour traumatisme grave, entre le 1er janvier 2009 et le 31 décembre 2014. L’intervention a consisté à la mise en place d’un réseau de soins entre les deux groupes. La mortalité hospitalière ajustée sur l’âge, le sexe et le score RTS étaient le critère de jugement principal. Résultats: Au total, 4 hôpitaux ont participé et ont inclus 195 patients consécutifs dans le groupe pré-interventionnel contre 9 hôpitaux et 210 patients dans le groupe post-interventionnel. Entre les deux groupes, le taux d’admission directe s’est amélioré (48,6 % vs 75,9 %) ainsi que le temps d’arrivée à l’hôpital (6,5 h vs 4,2 h). Il a été relevé une diminution des volumes de perfusion associée à une augmentation des taux d’utilisation des catécholamines (2% vs 6,6 %), de la transfusion sanguine (15,8 % vs 25,7 %) et de l’acide tranexamique (zéro % vs 77,6 %). Le taux d’intubationen cas de GCS &lt; 9 (13,2 % vs 37 %), d’administration de mannitol en présence d’une mydriase (58 % vs 72,4 %) et de réalisation du scanner cérébral chez les patients ayant un GCS ≤14 (10,6 % vs 54,6%) ont augmenté également. En revanche, le pourcentage de patients ayant bénéficié d’un&nbsp; drainage thoracique (0,5 % vs 1,4 %) et la fréquence d’actes de chirurgie (43 % vs 50 %) n’ont pas significativement varié. La mortalité, quant à elle,&nbsp; est significativement passée de 73,3 % à 54,7 %. Conclusion: Une amélioration des pratiques et une baisse de la mortalité ont été observées après&nbsp; la mise en place du réseau de soins. &nbsp; English title: Impact of the establishment of a severe trauma care network in the City of Kinshasa, Democratic Republic of the Congo: a quasi-experimental study Context and objective: Better management is mandatory for avoidable post-traumatic deaths. This study aimed to assess the impact of the&nbsp; implementation of a trauma network on the mortality of severe trauma patients in Kinshasa, DR Congo. Methods: The multicentric quasic-experimental before/after survey included adult patients admitted in intensive care unit for trauma in Kinshasa&nbsp; between January 2009 and December 2014. The relevance of the implementation of a trauma network was assessed. In-hospital mortality adjusted&nbsp; for age, gender and RTS score was the primary endpoint. Results: A total of 195 consecutive patients was concerned from 4 hospitals in the pre-intervention group vs 210 patients from 9 hospitals in the&nbsp; postintervention group. In the two groups, the direct admission rate improved (48.6 % vs 75.9 %) as well as the time of arrival at the hospital (4.2 h&nbsp; vs 6.5 h). There was a decrease in infusion volumes associated with an increase utilization rate of catecholamines 2 % vs. 6.6 %), blood transfusion (15.8 % vs. 25.7 %) and acid tranexamic (0 % vs 77.6 %). The rate of intubation in the event of GCS &lt; 9 (13.2 % vs 37 %), administration of mannitol in&nbsp; the presence of mydriasis (58 % vs 72.4 %) and realization of the brain scan in patients with a GCS ≤14 (10.6 % vs&nbsp; 4.6 %) also increased. However, the&nbsp; percentage of patients who received chest drainage (0.5 % vs&nbsp; 1.4 %) and the frequency of surgery (43 % vs 50 %) did not vary significantly. Mortality, meanwhile, fell from 73.3 % to 54.7 %. Conclusion: An improvement in practices and a reduction in mortality were observed after the&nbsp; implementation of the trauma network