Researches at CTD

The Directorate's research activities can generally fall into the following spectra, early to late phase of clinical trials including: Drugs trial, Vaccines trial, Medical devices trial, Diagnostics TrialClinical development of traditional/herbal medicinal products, Bioequivalence studies, Clinical pharmacology studies, Pharmacovigilance studies, drugs and vaccines field effectiveness and impact assessments to.

Accordingly, the CTD currently has the following   divisions:

• Drugs Trial Division
• Vaccines, diagnostics and medical devices Trials Division
• Bioequivalence & Clinical Pharmacology Division
• Trials Management and Quality Assurance Division

Selected & Featured Clinical Trials, Studies @ CTD

1. Drugs, Vaccines, Medical Devices and Diagnostic Trials

STREAM stage 2 (Completed): Site PI: Dr. Adamu Bayissa; 2016-2022

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): Site PI: Dr. Tesfamariam Mebrahtu; 2012-2020

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.

bCPAP (Completed): Site PI: Dr. Meseret Gebre, Co-PI: Dr Kassa Haile in collaboration with icddrb, Bangladesh; 2020-2022

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 was 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.

LAMPREG (On-going): Local PIs: Dr Abebe, Genetu, Dr Mekonnen Teferi in collaboration with University of Calgary & Co-PIs at JU & APHI; since 2021

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 from malaria.

ECCP, OCV Effectiveness in real life setting (On-going): Local PI: Dr Mekonnnen Teferi in collaboration with the International Vaccine Institute (IVI); since 2021

The Ethiopian Cholera Control and Prevention (ECCP) project was initiated as a follow-up of our collaboration with the International Vaccine Institute (IVI) on OCV (oral cholera vaccine). It is mainly assessing the effectiveness and impact of OCV in the control and prevention of cholera in real world setting through an enhanced sentinel diarrheal diseases surveillance around Shashemene, Oromia regional state, Ethiopia.

SOLIDARITY Trial and SOLIDARITY trial Plus for the treatment of COVID-19 (Completed) – Country PI & Coordinator: Drs Emawayish Tesema & Mekonnen Teferi in collaboration with site investigators at Eka Kotebe General Hospital and the WHO SOLIDARITY team; 2020-2023

This is part of the WHO initiative of SOLIDARITY Therapeutics groups in search of treatment to  COVID-19 as part of the global 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 Remdesivir against the standard of care was conducted in Ethiopia in collaboration with the Eka Kotebe General Hospital; then with three more products (i.e. Artesunate, Imatinib and Infliximab) that run until the WHO team decided to stop recruitment, March 2023.

Mvent, Clinical Evaluation of Locally made Mechanical ventilator in Ethiopia (Completed): PI:  Dr Kassa Haile and Dr Ananya Abate; 2021-2022

This study was proposed to pilot whether a locally assembled, an automated ambu bag based mechanical ventilator can properly interact and respond to patient’s need. Such need based local innovations were part of the emergency response during the COVID-19 pandemic. Lessons were learnt particularly in the clinical development of locally innovated medical devices.

OCV Bridging trial (Completed): Site PI: Dr Abraham Aseffa and Co-PI: Dr Zenebe Akalu in collaboration with the International Vaccine Institute (IVI); 2013-2014

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

4FDC (Completed): Lcoal PI: Dr Abraham Aseffa; 2006

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

THyB3 (Completed): Site PI: Dr Jemal Hussein in collaboration with SSI, Denmark; 2010

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.

2. Bioequivalence studies

Lead 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 have experiences with ciprofloxacin and contrimoxazol tablets in a pilot and pivotal studies. 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 as part of the EDCTP supported DPP (Developing Pediatric Primaquine) project.

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. Accordingly, we are currently engaged in development of a full-fledged BE center with clinical and bioanalytical laboratory facilities.      

3. Others

 Pharmacovigilance studies

The directorate has been part of the 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. In parallel, the performance of Ethiopian active drugs safety monitoring (aDSM) gainst new anti-TB drugs was evaluated.

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

Oumer Ali Ahmed
Senior Researcher /MD, MSc, PHD/
Research Interest: Infectious Diseases, NTD
Email: Oumer2003@gmail.com
Tel: +251911408208

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

Hawult Taye Adane
Senior Researcher /MPH, PHD/
Research Interest: Epidemiology, Trials Methods
Email: hawultachew@gmail.com
Tel:  +251911535973

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

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

Tadiye Abeje
- (MD, MPH)
Research Interest:
Email:
Tel: +251912055473

Bethlehem Solomon
Associate Researcher (MD)
Research Interest: Public health

Edilawit Mesfin
Study Coordinator (MD)
Research Interest: Vaccine research

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

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, MPH)
Research Interest: Clinical Trial Infectious Disease
Email: simagenet19@gmail.com
Tel: +251917500948

Melat Gebremedhin Teklewold
Assistant Researcher  (BSc, MPH)
Research Interest: Research Bioethics, Clinical Trial drug development
Email: melatgebremedhin5@gmail.com
Tel: +251936-960547

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

Yajeb Melese
Assistant Researcher (Bpharm, MSc)
Research Interest: Bioequivalence

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

Derso Furgassa
Assistant Researcher (BSc lab Tech)
Research Interest: Clinical Trial
Email: dersoyek@gmail.com

Publications

Selected & Featured Publications

Goodall RL, Meredith SK, Nunn AJ, Bayissa A, Bhatnagar AK, Bronson G, Chiang CY, Conradie F, Gurumurthy M, Kirenga B, Kiria N, Meressa D, Moodliar R, Narendran G, Ngubane N, Rassool M, Sanders K, Solanki R, Squire SB, Torrea G, Tsogt B, Tudor E, Van Deun A, Rusen ID; STREAM study collaborators. Evaluation of two short standardised regimens for the treatment of rifampicin-resistant tuberculosis (STREAM stage 2): an open-label, multicentre, randomised, non-inferiority trial. Lancet. 2022 Nov 26;400(10366):1858-1868. doi: 10.1016/S0140-6736(22)02078-5. Epub 2022 Nov 8.PMID: 36368336 

Rosu L, Madan JJ, Tomeny EM, Muniyandi M, Nidoi J, Girma M, Vilc V, Bindroo P, Dhandhukiya R, Bayissa AK, Meressa D, Narendran G, Solanki R, Bhatnagar AK, Tudor E, Kirenga B, Meredith SK, Nunn AJ, Bronson G, Rusen ID, Squire SB, Worrall E; STREAM Study Health Economic Evaluation Collaborators. Economic evaluation of shortened, bedaquiline-containing treatment regimens for rifampicin-resistant tuberculosis (STREAM stage 2): a within-trial analysis of a randomised controlled trial. Lancet Glob Health. 2023 Feb;11(2):e265-e277. doi: 10.1016/S2214-109X(22)00498-3. Epub 2022 Dec 21.PMID: 36565704

Tiemersma EW, Ali I, Alemu A, Avong YK, Duga A, Elagbaje C, Isah A, Kay A, Mmbaga BT, Mmari E, Mwamwitwa K, Nhlabatsi S, Sintayehu K, Arefayne A, Teferi M, Cobelens F, Härmark L. Baseline assessment of pharmacovigilance activities in four sub-Saharan African countries: a perspective on tuberculosis.BMC Health Serv Res. 2021 Oct 8;21(1):1062. doi: 10.1186/s12913-021-07043-6.PMID: 34625085

 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 

Graduate students

Abel Mathewos Tilahun
Assistant Researcher (B.Pharm, MSc student)
Research Interest: Clinical pharmacology
Email: abelmathewos86@gmail.com
Tel: +251910629286

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

  

A new project RER-CTO (Reinforce the Ethical and Regulatory Ecosystem for the Transformation of Clinical Trials Oversight in Ethiopia, Tanzania and beyond) aimed at achieving excellence and harmonization in clinical trial oversight across sub-Saharan Africa has been launched, backed by nearly 1 million euros in funding from the Global Health EDCTP3 Joint Undertaking on July 01, 2024.

RER-CTO brings together seven leading institutions: the University of Oslo, Karolinska Institute, Armauer Hansen Research Institute, Tanzania Medicines and Medical Devices Authority, Ethiopian Food and Drug Authority, National Institute for Medical Research, and Ethiopia’s Ministry of Education.

RER-CTO coordinated by the University of Oslo, and Armauer Hansen Research Institute (AHRI) of Ethiopia, will take the Scientific lead of this research with Dr. Kassa Haile.

Objectives:

• Reinforce policy and legal framework for clinical trial oversight in Ethiopia, Tanzania and beyond.
• Improve regulatory and research ethics oversight capacity and capability in Ethiopia, Tanzania and beyond.
• Strengthen local, regional, and international collaborations and coordination of NECs and NRAs for clinical trial oversight in Ethiopia, Tanzania and beyond.

The three-year project aims to bolster the capacity and capability of national regulatory authorities (NRAs) and national ethics committees (NECs) in Ethiopia and Tanzania. The focus is on improving legal and policy frameworks, enhancing regulatory and research ethics oversight, and fostering stronger collaborations at local, regional, and international levels.

By the end of its term, RER-CTO seeks to set new standards for ethics and regulatory functions in the region, ensuring robust and harmonized clinical trial oversight that aligns with global best practices.