Category : CLINICAL SITES | Date : Oct 23, 2019

October 2019 – Evaluation visit in Madagascar

In October 2019, an INTENSE-TBM team performed the evaluation visit of the clinical sites and laboratories in Madagascar.

The evaluation team was composed of Dr. Juan Ambrosioni, INTENSE-TBM co-investigator and WP2-leader (IDIBAPS), and 2 biologists: Eva Ariza Vioque, study coordinator (IDIBAPS) and Holy Nandrianina Andriamamonjisoa (IPM).

The purpose of this visit was to assess whether the capacity needs of clinical sites and laboratories are being met and to put in place the appropriate procedures to ensure that all sites are ready to recruit patients and process samples in 2020.
In the clinical sites, the assessed items were about human resources; procedures and performance (i.e. pulmonary/CFS specimen collection, storage and shipment); infrastructure, equipment and supplies; data management and infection control.

In the laboratories, the assessed items were about human resources; procedures and performance (i.e. specimen collection, storage and shipment, GeneXpert procedures, culture procedures, drug sensibility testing…); data management; laboratory infrastructure, equipment and supplies; biosafety control and quality management system.

Dr. Mihaja Raberahona, country principal investigator (CICM), Dr. Haingo Razafindrakoto, country trial manager (CICM), Dr. Niaina Rakotosamimanana, trial co-investigator (IPM) and Pr. Rivo Rakotoarivelo, site principal investigator in Tambohobe, Fianarantsoa
welcomed the INTENSE-TBM evaluation team.

In Madagascar, patients will be recruited at three clinical sites:

  • Hôpital Universitaire Joseph Raseta Befelatanana (Antananarivo)
  • Hôpital Universitaire Tambohobe (Fianarantsoa)
  • Hôpital Universitaire Morafeno (Toamasina)