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                 ‘Promoting Evidence Based Medicine’

 Clinical Trials Directorate (CTD)arch

  • About CTD
  • Research
  • Researchers at CTD
  • Publication
  • Graduate Students
  • Contact

About CTD

Since its first initiation of GCP compliant clinical trial in 2001, the Clinical Trial Directorate (CTD) conducts various drugs, vaccines, and devices trials; as well as Bioequivalence and pharmacovigilance studies. We are devoted to the design, protocol writing, conduct, management, monitoring and reporting of clinical trials for academic and regulatory purposes. Strengthening the local heath innovation and clinical development of traditional medicines are areas of potential collaboration for improvement of patient care in the country thus CTD is working towards these. We are also mandated for capacity building, trainings such as GCP, quality management and community engagement in improving the clinical trial environment in the country.

The CTD currently has a clinical trial site with phase I trial facilities including study ward, safety clinical laboratory and acquired experiences in setting up collaborating satellite trial sites in several health care facilities in Addis Ababa and beyond when deemed necessary.

Research

The Directorate's research activities can generally fall into the following categories of clinical studies: Drugs trial, Vaccines trial, Medical devices trial, Clinical Pharmacology including Bioequivalence studies, Pharmacovigilance studies, Clinical development of traditional medicine /herbal products/ and other translational clinical studies.

Accordingly, the CTD can functionally has the following research teams:

  • Drugs & vaccines research team
  • Clinical Pharmacology team; Bioequivalence & Pharmacovigilance studies 
  • Traditional Medicines Clinical Development Team
  • Medical devices & other translational medicines team
  • Clinical Trial Quality Assurance Unit

Selected & Featured Clinical Trials/Studies @ CTD

  1. Drugs Trial

STREAM stage 2 (Ongoing): Led by Dr. Adamu Bayissa

The Evaluation of Standardized Treatment Regimen of Anti-TB drugs for patients with MDR TB (STREAM II ) is an international multicenter randomized controlled phase III trial with a non-inferiority design comparing all oral MDR TB drugs against injectable regimen.

It is sponsored by Vital Strategies (the UNION) and funded by USAID and Janssen Pvt.

STREAM stage 1 (Completed): Led by Dr. Tesfamariam Mebrahtu

The Evaluation of Standardized Treatment Regimen of Anti-TB drugs for patients with MDR TB (STREAM II ) is an international multicenter randomized controlled phase III trial with a non-inferiority design comparing a 9 months regimen against the 18-24 months WHO regimen for the treatment of MDR TB patients. It proved the non-inferiority of the shorted regimen and was endorsed by WHO as standard of care in the management of MDRTB patients.

It is sponsored by Vital Strategies (the UNION) and funded by USAID.

SOLIDARITY trial for the treatment of COVID-19 (on-going) – Led by Drs Mekonnen Teferi & Emawayish Tesema in collaboration with site investigators

This is part of the WHO initiative of SOLIDARITY for enhancing innovation to drugs, vaccines and diagnostics against COVID-19 as part of the public health response to the pandemic. The therapeutics group was initiated with testing re-purposed and new drugs for the treatment of COVID-19 during the earliest period of the pandemic, March 2020. Ethiopia joined the initiative later in October through the co-sponsorship of the MOH where CTD of AHRI lead the trial in Ethiopia. Therefore, the first round of testing was conducted in Ethiopia in collaboration with the Eka Kotebe General Hospital using Remdesivir. Currently data cleaning and analysis is on-going pending protocol amendment with three new products.

4FDC (Completed): Led by Dr Abraham Aseffa

Efficacy and Safety of ‘Fixed Dose’ versus ‘Loose’ Drug Regimens for Treatment of Pulmonary Tuberculosis in Two High TB-Burden African Countries: A Randomized Controlled Trial

  1. Vaccine Trials

OCV Bridging trial (Completed): Led by Drs Abraham Aseffa and Zenebe Akalu

Randomized, Placebo-Controlled Trial Evaluating Safety and Immunogenicity of the Killed, Bivalent, Whole-Cell Oral Cholera Vaccine in Ethiopia. (Completed in 2014)

THyB3 (Completed): Led by Dr Jemal Hussein

A phase I, open-label trial on the safety and immunogenicity of the adjuvanted tuberculosis subunit vaccine H1/IC31® in people living in a TB-endemic area. (completed in 2010)

  1. Device Trials

bCPAP (Ongoing): Led by: Dr. Meseret Gebre

Pneumonia is the leading cause of under-five mortality in Ethiopia. Different studies have shown the positive impact of providing oxygen therapy via bubble CPAP for hypoxemic children. However, operational challenges related to introduction and clinical use of bubble CPAP essentially requires further evaluation.

The aim of BCPAP clinical trial is to evaluate the feasibility and acceptability of bubble CPAP in treating childhood pneumonia initially in two tertiaries followed by two district hospitals (stages 1&2) and finally to assess the effectiveness of bubble CPAP in reducing death and/or treatment failure in children with severe pneumonia in stage 3 compared with the WHO standard low-flow oxygen therapy among children hospitalized with severe pneumonia in Ethiopia.

Mvent (Upcoming): Led by Dr Kassa Haile

Clinical Evaluation of Locally made Mechanical ventilator in Ethiopia.

This project is currently under review for approval from ECs and regulatory bodies.

  1. Diagnostic Trials

LAMPREG (Upcoming): Led by Drs Rediet Fikru & Zelealem Mekonnen (PI- Dr Abebe Genetu)

LAMPREG is a pragmatic randomized control diagnostic trial which will be conducted in pregnant mothers at six sites in Ethiopia. First and second trimester pregnant women will be included in the study and individually randomized to either standard of care or enhanced cased detection arms using LAMP for malaria. In this study, we propose that the use of a highly sensitive LAMP technique will enable us to detect more asymptomatic Plasmodium infections in pregnant women. This consequently results in early treatment of the pregnant mothers and may avert maternal and fetal morbidity and mortality. This project is currently under review for approval from relevant bodies.

  1. Bioequivalence studies

Led by Dr Mekonnen Teferi

The CTD took the national initiative for the conduct of the first BE study in Ethiopia in collaboration with the Regional Bioequivalence Center in Addis Ababa in 2014. Since then, we conducted two pilot studies and one pivotal study for WHO pre-qualification. Our site had a pre-inspection experience with WHO auditors in 2015. Currently the site is working for WHO pre-qualification submission of a new pediatric formulation of primaquine in collaboration with different partners abroad.

The BE center at AHRI is part of the national capacity building effort by the MOH in ensuring the safety and efficacy of generic products in Ethiopia and beyond.

  1. Pharmacovigilance studies

Led by Dr Mekonnen Teferi

The directorate currently hosting a consortium project on strengthening pharmacovigilance (PV) system in Africa called PAVIA. This is a kind of platform that may facilitate capacity building for monitoring safety of post-licensure and pre-maturely approved new products such as anti-TB drugs in Africa. Therefore, the project is implemented in collaboration with the Ethiopian Food and Drugs Authority and the national TB program for strengthening the PV system through training, supportive supervision of MDRTB TICs and analysis of safety reports. 

PAVIA is a platform for strengthening safety monitoring at the regulatory and post marketing safety investigations by medical research institutes with special interest on newly introduced medicinal products.

  1. Social Science Studies

SaLTs (Ongoing): Led by Dr Kassa Haile

Undergoing program evaluation to review the outcomes of the national safe surgery strategy, the changes brought about through the SaLTS flag-ship program, and also document the lessons learned in public and private health facilities in Ethiopia.

ACESS Africa (Ongoing): Led by Yemiserach Zewde

Improving post-trial access arrangements in clinical trials in Sub-Saharan Africa; Acess AFRICA Study.

Researchers at CTD

The CTD staff are constituted of different discipline that may include graduates of natural sciences such as nurses, medical doctors, pharmacists, public health professionals, laboratory personnel, biomedical fields as well as social sciences.

Meseret Gebre Behute
Researcher (MD, Pediatrician)
Research Interest: Pediatric Infectious Diseases
Email: meseret.gebre@ahri.gov.et 
Tel: +251911977885

 

Adamu Bayissa
Researcher (MD, MPH)
Research Interest: CT in drug development
Email:adamubayissa@ahri.gov.et
Tel: +251929041898

 

Kassa Haile
Researcher (MD, MPH)
Research Interest: Clinical trial, drug/device trial
Email: Kassa.haile@ahri.gov.et
Tel: +251911396555

 

Mekonnen Teferi Mekonnen
Researcher (DVM, MPharm)
Research Interest: Product clinical development, Clinical pharmacology, Pharmacovigillance
Email: mekonnen.teferi@ahri.gov.et
Tel: +251911103233

 

Zelalem Mekonnen Bekele
Researcher (MD, MSc)
Research Interest: Clinical Trial in Vaccine/ Drug Development 
Email: zelealem.mekonnen@ahri.gov.et
Tel: +251943412379

 

Rediet Fikru Gebresenbet
Associate Researcher (MD, MPH)
Research Interest: Clinical trial in infectious diseases
Email:redietbibo@gmail.com
Tel: +251913169540

 

Fiker Taddesse Seyoume
Associate Researcher (MD, MSc)
Research Interest: Clinical trial in Drugs for Non communicable diseases
Email:fiker.taddesse@gmail.com
Tel: +251911820354

 

Filmona Mekuria Asfaw
Associate Researcher (MD, MPH)
Research Interest: Clinical trial in infectious diseases
Email: filmona.tina@gmail.com  
Tel: +251910220332

 

Daniel Legese Achalu
Assistant Researcher (B.pharm, MBA, MSc student)
Research Interest: Pharmacoepidemiological Researches
Email: danigateline@gmail.com 
Tel: +251912750932

 

Helen Teklu Tesfaye
Associate Researcher (BSc Nurse, MPH)
Research Interest: NCD
Email: Tek1helena@yahoo.com 
Tel: +251911481420

 

Helina Seid Yimer
Research nurse
Research Interest: Maternal and child health
Email: helinaseid@yahoo.com
Tel: +251913286835

 

Miheret Fikre Teklemariam
Assistant Researcher (BSc Nurse, MSc in HSM)
Research Interest: Health systems research, health policy
Email:miheretliya@gmail.com
Tel: +251911347454

 

Muluye Shimelis Getahun
Assistant Researcher (BSc in Medical laboratory)
Research Interest: Clinical Trial Quality and monitoring
Email: mullerbecha@gmail.com
Tel: +251911368499

 

Netsanet Aragaw Tegegne
Assistant Researcher (BSc Nurse, MPH)
Research Interest: Clinical trial in infectious disease
Email: netsuhe2014@gmail.com
Tel: +251911357189

 

Simon Genet Woldesenbet
Health Assistant Researcher (BSc Nurse, MBA)
Research Interest: Clinical Trial Infectious Disease
Email: simagenet19@gmail.com
Tel: +251917500948

 

Ermias Hundito Abebe
Assistant Researcher (BSc in Public health)
Research Interest: Drug development in infectious and non-infectious diseases
Email:ermiashundito@yahoo.com
Tel: +251916303538

 

Yemisrach Zewdie Seralegne
Associate Researcher (B.A, M.A)
Research Interest: Clinical trials in post-trial access
Email:yemzewd@gmail.com
Tel: +251911154197

 

Bilcha Tadesse Haile
Research Nurse
Research Interest: Clinical trial infectious disease
Email:bilchayared@gmail.com
Tel: +251920999588

 

Ebrahim Nursefa wondmu
Junior Researcher (Bsc Laboratory technology)
Research Interest: Clinical Trial Infectious Disease
Email: Ibranur2369@gmail.com
Tel: +251925938528

 

Frehiwot Tameru Negussie
Junior Researcher (Bsc in laboratory technology)
Research Interest: Clinical trial in infectious disease
Email: frehwottamiru@gmail.com
Tel: +251911867895

Publications

Selected & Featured Publications

An African, multi-centre evaluation of patient care and clinical outcomes for patients with COVID-19 infection admitted to high-care or intensive care units. www.thelancet.com 

THELANCET-D-20-19435 – accepted for publication

A Trial of a Shorter Regimen for Rifampin-Resistant Tuberculosis.

Nunn AJ, Phillips PPJ, Meredith SK, Chiang CY, Conradie F, Dalai D, van Deun A, Dat PT, Lan N, Master I, Mebrahtu T, Meressa D, Moodliar R, Ngubane N, Sanders K, Squire SB, Torrea G, Tsogt B, Rusen ID; STREAM Study Collaborators.N Engl J Med. 2019 Mar 28;380(13):1201-1213. doi: 10.1056/NEJMoa1811867. Epub 2019 Mar 13.PMCID: 30865791 

Efficacy and Safety of ‘Fixed Dose’ versus ‘Loose’ Drug Regimens for Treatment of Pulmonary Tuberculosis in Two High TB-Burden African Countries: A Randomized Controlled Trial.

Abraham Aseffa, Joseph N. Chukwu, Mahnaz Vahedi, Emmanuel N. Aguwa, Ahmed Bedru, Tesfamariam Mebrahtu, Oliver C. Ezechi, Getnet Yimer, Lawrence K. Yamuah, Girmay Medhin, Cathy Connolly, Wasima Rida, Getachew Aderaye, Alimuddin I. Zumla, Philip C. Onyebujoh, 4FDC Study Group

PLoS One. 2016; 11(6): e0157434. Published online 2016 Jun 20. doi: 10.1371/journal.pone.0157434 PMCID: PMC4913909

A phase I, open-label trial on the safety and immunogenicity of the adjuvanted tuberculosis subunit vaccine H1/IC31® in people living in a TB-endemic area.

Jemal Hussein, Martha Zewdie, Lawrence Yamuah, Ahmed Bedru, Markos Abebe, Alemnew F. Dagnew, Menberework Chanyalew, Asfawesen G. Yohannes, Jemal Ahmed, Howard Engers, T. Mark Doherty, Peter Bang, Ingrid Kromann, Søren T. Hoff, Abraham Aseffa

Trials. 2018; 19: 24. Published online 2018 Jan 10. doi: 10.1186/s13063-017-2354-0PMCID: PMC5764015

A Randomized, Placebo-Controlled Trial Evaluating Safety and Immunogenicity of the Killed, Bivalent, Whole-Cell Oral Cholera Vaccine in Ethiopia.

Sachin N. Desai, Zenebe Akalu, Samuel Teshome, Mekonnen Teferi, Lawrence Yamuah, Deok Ryun Kim, Jae Seung Yang, Jemal Hussein, Ju Yeong Park, Mi Seon Jang, Chalachew Mesganaw, Hawult Taye, Demissew Beyene, Ahmed Bedru, Ajit Pal Singh, Thomas F. Wierzba, Abraham Aseffa

Am J Trop Med Hyg. 2015 Sep 2; 93(3): 527–533. doi: 10.4269/ajtmh.14-0683; PMCID: PMC4559691

Comparison of immune responses to a killed bivalent whole cell oral cholera vaccine between endemic and less endemic settings.

Desai SN, Akalu Z, Teferi M, Manna B, Teshome S, Park JY, Yang JS, Kim DR, Kanungo S, Digilio L.Trop Med Int Health. 2016 Feb;21(2):194-201. doi: 10.1111/tmi.12641. Epub 2015 Dec 18.PMID: 26681205

Safety of a trivalent meningococcal ACW135 vaccine among young children in Ethiopia.

Aseffa A, Bedru A, Yamuah L, Arga D, Worku A, Chandramohan D, Nelson CB, Engers HD. Vaccine. 2007 Sep 3;25 Suppl 1:A79-82. doi: 10.1016/j.vaccine.2007.04.046. Epub 2007 May 4. PMID: 17548138 

Postgraduate Students

PhD Fellows

Oumer Ali Ahmed
Researcher (MD, MSc, PhD fellow at CDT- Africa & BSMS)
Research Interest: Clinical trial on diseases of public health importance

 

Title of research project:  Impact of a holistic integrated care package on clinical and Psychosocial outcomes for people with lower limb disorders secondary to Podoconiosis, Lymphatic Filariasis & Leprosy in Awi Zone, Ethiopia. 
Email: Oumer2003@gmail.com
Tel: +251911408208

Hawult Taye Adane
Researcher (BSc, MPH, PhD Fellow)
Research Interest: Observational studies, Clinical epidemiology

 

Title of research project: Clinical and Molecular Epidemiology of tuberculosis among humans living or working around peripheral urban areas in Ethiopia.
Email: hawultachew@gmail.com
Tel: +251911535973

Masters students

Abel Mathewos Tilahun
Assistant Researcher (B.Pharm, MSc student)
Research Interest: Clinical trial in drug/vaccine development
Email: abelmathewos86@gmail.com
Tel: +251910629286

Hiwot Asmerom
Health Assistant Researcher II (BSc Nurse, MSc student)
Research Interest: Clinical Trial Infectious Disease
Email: asmeromhiwot5@gmail.com
Tel: +251911483571

Contact


Dr. Mekonnen Teferi
Director,Clinical Trial Directorate
Email: mekonnen.teferi@ahri.gov.et
Tel: +251911103233