Publications des scientifiques de l'IRD

Alirol E., Horie N. S., Barbe B., Lejon Veerle, Verdonck K., Gillet P., Jacobs J., Buscher P., Kanal B., Bhattarai N. R., El Safi S., Phe T., Lim K., Leng L., Lutumba P., Mukendi D., Bottieau E., Boelaert M., Rijal S., Chappuis F. (2016). Diagnosis of persistent fever in the tropics : set of standard operating procedures used in the NIDIAG febrile syndrome study. Plos Neglected Tropical Diseases, 10 (11), p. e0004749 [7 p.]. ISSN 1935-2735.

Titre du document
Diagnosis of persistent fever in the tropics : set of standard operating procedures used in the NIDIAG febrile syndrome study
Année de publication
2016
Type de document
Article référencé dans le Web of Science WOS:000392154400004
Auteurs
Alirol E., Horie N. S., Barbe B., Lejon Veerle, Verdonck K., Gillet P., Jacobs J., Buscher P., Kanal B., Bhattarai N. R., El Safi S., Phe T., Lim K., Leng L., Lutumba P., Mukendi D., Bottieau E., Boelaert M., Rijal S., Chappuis F.
Source
Plos Neglected Tropical Diseases, 2016, 10 (11), p. e0004749 [7 p.] ISSN 1935-2735
In resource-limited settings, the scarcity of skilled personnel and adequate laboratory facilities makes the differential diagnosis of fevers complex [1-5]. Febrile illnesses are diagnosed clinically in most rural centers, and both Rapid Diagnostic Tests (RDTs) and clinical algorithms can be valuable aids to health workers and facilitate therapeutic decisions [6,7]. The persistent fever syndrome targeted by NIDIAG is defined as presence of fever for at least one week. The NIDIAG clinical research consortium focused on potentially severe and treatable infections and therefore targeted the following conditions as differential diagnosis of persistent fever: visceral leishmaniasis (VL), human African trypanosomiasis (HAT), enteric (typhoid and paratyphoid) fever, brucellosis, melioidosis, leptospirosis, malaria, tuberculosis, amoebic liver abscess, relapsing fever, HIV/AIDS, rickettsiosis, and other infectious diseases (e.g., pneumonia). From January 2013 to October 2014, a prospective clinical phase III diagnostic accuracy study was conducted in one site in Cambodia, two sites in Nepal, two sites in Democratic Republic of the Congo (DRC), and one site in Sudan (clinicaltrials.gov no. NCT01766830). The study objectives were to (1) determine the prevalence of the target diseases in patients presenting with persistent fever, (2) assess the predictive value of clinical and first-line laboratory features, and (3) assess the diagnostic accuracy of several RDTs for the diagnosis of the different target conditions. In order to ensure consistency across study sites and compliance with Good Clinical (Laboratory) Practices (GC[L]P) and other applicable regulatory requirements, a robust quality assurance system was developed and implemented prior to recruitment start. This symposium describes the different components of the quality assurance system, introduces the set of standard operating procedures (SOPs) specifically developed for the NIDIAG persistent fever syndrome study, and identifies key challenges encountered by study sites in conducting the study in compliance with this quality framework.
Plan de classement
Santé : généralités [050] ; Entomologie médicale / Parasitologie / Virologie [052]
Description Géographique
CAMBODGE ; SOUDAN ; NEPAL ; REPUBLIQUE DEMOCRATIQUE DU CONGO
Localisation
Fonds IRD [F B010068911]
Identifiant IRD
fdi:010068911
Contact