Just before the outbreak of the Covid pandemic, it was challenging for Anita Wadagni from Benin to complete her Thesis; it took another year to have the ceremony organized online; she successfully defended her Thesis in March, 2021. The pandemic impacted on low-resource settings like Ghana and Benin, but also in affluent regions including Victoria, Australia. Activities of the BuG Foundation also slowed down.
in 2020 werd een totaalbedrag van € 2574,66 voor studentenprojecten in Afrika uitgekeerd; vermeerderd met diverse (m.n. bank-)kosten waren de uitgaven in totaal € 2816,32; inkomsten waren € 5365,60.
In 2021 werd € 1200,00 uitgekeerd voor onderzoek door studenten in Afrika; totaal aan uitgaven bedroeg € 1410,07; inkomsten bedroegen € 3896,48.
In juni 2022 hield prof Stienstra haar oratie als hoogleraar Infectieziekten, en werden diverse particuliere donaties voor de Stichting BuG ontvangen; de totale inkomsten waren € 3896,48; € 1200,00 werd uitgekeerd voor studentenonderzoek in Afrika waarbij onderzoek naar andere Neglected Tropical Diseases dan Buruli ulcer, zoals slangenbeten-onderzoek, ondersteund werd; de totale uitgaven bedroegen € 1410,07.
In 2023 waren de inkomsten € 3448,43; aan studenten-onderzoek in Afrika werd € 2239,79 uitgekeerd; totale uitgaven bedroegen € 2536,98.
per 28/10/2024 was het totaal-banktegoed van Stichting BuG € 23247,84.
| Tjip van der Werf, secretaris-penningmeester, Stichting Buruli ulcer Groningen |
financieel overzicht activiteiten 2014-2020
Op de zakelijke rekening ING Stichting BUG IBAN NL INGB 0007297759 (BIC: INGBNL2A) was het positief saldo dd 17-10-2020: 18.360,30 Euro.
Evenals in voorafgaande jaren werden bijdragen verkregen via vergoedingen voor medische adviezen, wetenschappelijke voordrachten, cursussen, royalties en publicaties – m.n. UpToDate en Nederlandse uitgeverijen.
Bij de bestedingen was er een geleidelijke verschuiving van ondersteuning van Nederlandse (m.n. Groningse) studenten die onderzoeks-stages op het terrein van Buruli ulcer in het buitenland deden, naar activiteiten bij tuberculose-onderzoek en onderzoek naar tropische slangenbeten en andere genegeerde infectieziekten die veel in de tropen voorkomen, zoals scabiës (schurft). Die verschuiving wordt verklaard door de enorme vooruitgang die al is geboekt op het terrein van onderzoek en behandeling van Buruli ulcer; inmiddels weten we dat de behandeling – mits de ziekte tijdig wordt opgespoord – met een antibiotische kuur van 8 weken vrijwel steeds tot volledige genezing leidt, met betrekkelijk weinig blijvende schade en beperkingen. Veruit de meeste ondersteunde projecten werden in Afrika uitgevoerd; daarnaast waren er researchprojecten in Australië, de VS, en Indonesië. Eenmalig werd een een PhD studente ondersteund met een bijdrage, en werd het haar co-promotor mogelijk gemaakt van uit Indonesië om de promotie in Groningen te kunnen bijwonen, door een bijdrage in de reiskosten.
Enkele Afrikaanse onderzoekers werden gesteund met bijdragen t.b.v. onderzoek, en in de rapportage-periode voltooiden drie PhD studenten uit lage inkomenslanden hun promotietraject met een verdediging van hun proefschrift aan de RuG.
Naast de acht promotietrajecten die aan de RuG zijn voltooid over Buruli ulcer, is nu een negende project – van Anita Wadagni uit Benin – afgerond, het proefschrift is goedgekeurd door de Beoordelingscommissie maar de promotieplechtigheid is uitgesteld vanwege de corona pandemie.
In de afgelopen periode van bijna 6 jaren is in totaal 19.401,72 uitgekeerd; inkomsten uit diverse bronnen bedroeg 15.810,56 Euro.
2006 Y Stienstra
2012 WA Nienhuis
2015 M Alferink
2015 SA Klis
2016 J de Zeeuw
2016 YT Barogui
2017 NA Amissah
2019 TF Omansen
2021 AAC Wadagni
2006 Y Stienstra
2012 WA Nienhuis
2015 M Alferink
2015 SA Klis
2016 YT Barogui
2016 J de Zeeuw
2017 NA Amissah
2019 TF Omansen
Francisca Nana Afia Sarpong
According to rules of Good Clinical Practice, clinical trials should have a system in place with monitoring of data entry.
Francisca Sarpong is on National Service, joining the team of Dr Richard Phillips; she is involved in laboratory work in KCCR located at the campus of the Kwame Nkrumah University of Science & Technology (KNUST).
Francisca completed her Bachelor in Microbiology at KNUST; she travelled to Groningen to receive education in principles of Evidence-Based Medicine and successfully passed her exam in Good Clinical Practice.
She returned to Ghana and arrived safely earlier today.
We hope to work with Francisca who will visit the study sites and check all data entries, trying to identify any mistakes and helping to improve the quality of the data entry.
She will report to the responsible officers at the study sites, the co-Principal Investigators and deputies (Dr Richard Phillips, Dr Fred Stephen Sarfo and Dr Annick Chauty) and Principal Investigator (Prof Tjip van der Werf), the study sponsor at WHO (Dr Kingsley Asiedu).
She will also work with the DNDi statisticians in Nairobi (Raymond Omollo and Michael Ochieng).
Wellcome in the team, Francisca!
Introduction: progress report WHO SR8/CR8 drug trial, Ghana-Benin
After drafting the study protocol and obtaining Ethics Clearance from the Ghana Health Research Unit Ethics Committee and the National Ethics Review committee in Benin, the kick-off meeting in July, 2012, POD and wound care treatment training on-site at the five different study sites in Ghana and Benin, and two different training courses (with Certificates for all that passed the formal test – in Allada, Benin, 20111; and Kumasi, Ghana, July, 2012), the drug trial has commenced in early 2013. In February 2013, all sites were visited by a team headed by Dr Kingsley Asiedu, WHO, and Prof Tjip van der Werf, PI. Both of the co-PIs – Dr Richard Phillips, and Dr Annick Chauty were actively involved and a summary report was drafted – but at that time point only three of the five trial sites had started accruing study participants.
We now report on the second field trip with a team consisting of Dr Kingsley Asiedu, Prof Tjip van der Werf, Dr Edwin Ampadu, National BU Program Manager; with Mrs Linda Lehman focusing on POD; Dr Terry Treadwell and Dr John Macdonald focusing on wound care practices; and Prof Jérôme Robert, focusing on diagnostic confirmation testing. As in the earlier field trip in February, Raymond Omollo and Michael Ochieng, statisticians of DNDi, Nairobi, Kenya, provided support and assessed and solved problems with data entry into Open Clinica, the internet-based data management system that is used for the trial.
This time, the team decided to focus on the sites in Ghana, while Prof Robert alone continued his journey from Ghana to Benin to visit the site in Pobè, Benin.
Summary, second field assessment, December 2013
Accrual: improved after incentives provided by WHO from September/October; still slow, partly due to sub-optimal outreach activities; partly, due to administrative changes in District divisions, creating boundaries for the outreach teams.
Suggested improvement: formal negotiations with districts across boundaries to help enroll patients as study participants; different strategies will be applicable in different situations. The study gradually began to set off during the year of 2013, with Dunkwa the last site to be started, around mid-2013.
Overall performance: site study team members commitment and staff changes are a threat to the study.
Good Clinical Practice: new study team members should have crash-course GCP training with formal exam to meet GCP requirement.
SAE, SUSAR: Serious Adverse Events, Serious Unexpected Suspected Adverse Reactions: none
SAE: Adverse Events: only one case of transient dizziness in an elderly woman attributed to streptomycin was notices, and handled by stopping suspected causal medication – with beneficial effect.
Case holding: satisfactory; no serious drop-out rates. Patients that failed to report at follow-up visits were actively followed in their districts.
Protocol Violations: following the study protocol appeared fair but needs continuous attention; GCP, POD, wound care, data entry, ARANZ data acquisition and uploading equally deserve continuous attention but overall, the assessments were positive.
Supplies: drugs: still sufficient; Drawtex sufficient but resources are use for non-study cases with is a potential threat. Shortage of Vaseline gauze could be addressed by local production: product should be clean but not necessarily sterile. Gloves should be clean, not necessarily sterile.
Equipment: one ECG machine broke down, uncertain if it can be repaired; a new apparatus will be purchased by Tjip van der Werf, Groningen while Abass will attempt to have the old one repaired in Ghana, as a spare. Audiometry equipment all fine.
Transport: Burulico vehicle can be used if needed; Mr Abass coordinates in close collaboration with Agogo Management.
Monitoring: needs attention; a plan has been made to train a dedicated person, Miss Francisca Naana Sarpong, BhSc (Biology, KNUST) currently attached to the Department of Medicine – Infectious diseases (Dr Phillips), KATH, and active in Agogo, who is on the National Service program until mid-2014. She will be invited to Groningen, Netherlands for crash course in GCP and monitoring activities, and start formal monitoring activities for the trial end of January, after her training.
Reporting to Data Safety Monitoring Board and Ethics Committees: planned early January, 2014, after feed-back of this draft-report has ben obtained from all visiting team members.
Data entry into OpenClinica: as required by GCP, faults should always be corrected in such way, that monitors and auditors can see the original faulty data entry, as well as the date when, and the person who made the correction, by signing; corrections should be transparent. Delay in data entry has been noted at various sites – this poses a potential threat to improve data entry mistakes in time; data management staff have been further encouraged and instructed to prevent further delays.
Tjip van der Werf, University of Groningen, Principal Investigator; Kingsley Asiedu, WHO, Geneva, Neglected Tropical diseases Division, responsible for Buruli ulcer
Nkawie
Tepa
Stichting Buruli ulcer Groningen
Voorzitter: Prof Dr Ymkje Stienstra, internist-infectioloog, epidemioloog, UMCG, Groningen, en Liverpool School of Tropical Medicine
Secretaris – penningmeester: Prof Dr Tjip S van der Werf, longarts nop, emeritus hoogleraar Infectieziekten UMCG, RuG Groningen
leden: Mr Ria Overes – Hulst, voormalig kantonrechter te Groningen
Ds Pieter Dirk Wolthaus, Zutphen; emeritus predikant, PKN Groningen
Stichting Buruli ulcer Groningen
Voorzitter: Dr Ymkje Stienstra, internist-infectioloog, epidemioloog UMCG, Groningen
Secretaris – penningmeester: Prof Dr Tjip S van der Werf, longarts, hoogleraar Infectieziekten UMCG, RuG Groningen
leden: Prof Dr HH (Bart) van Ark, hoogleraar Economie RuG Groningen; chief economist, The Conference Board, New York, USA
Ds Pieter Dirk Wolthaus, em predikant PKN Groningen
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