Optimization of chemotherapy for control and elimination of onchocerciasis and lymphatic filariasis-ghana sites

Transcription

1 Optimization of chemotherapy for control and elimination of onchocerciasis and lymphatic filariasis-ghana sites Objective 2 Group: Bonn/Germany Kumasi/Ghana Prof. Achim Hoerauf Dr. Sabine Mand Dr. Alex Debrah

2 CURRENT STATUS OF ONCHO and LF CONTROL IN GHANA

3 Regional Distribution of NTDs Legend Trachoma, LF, Oncho, Schisto, STH LF, Oncho, Schisto, STH Oncho, Schisto, STH LF, Schisto, STH

4 Onchocerciasis is endemic in 9 out of 10 regions in Ghana About 3204 communities from 66 out of 110 districts have been compiled to be endemic in these regions Total at risk population is about 3.2M

5 Distribution of Oncho/LF Districts Number of Districts TOTAL Region LF Only Districts Oncho Only Districts LF/Oncho LF Oncho Western Central Greater Accra Upper East Upper West Northern Brong Ahafo Eastern Volta Ashanti TOTAL

6 Status and organization of national onchocerciasis elimination program Oncho activities started in Ghana in 1974 and focused on aerial larviciding Ivermectin distribution in Ghana started with the use of mobile teams in 1987 CDTI was introduced in 1998

7 Ivermectin treatment started in LF/Oncho coendemic areas in 2001 There was a gradual up-scaling to finally cover 61 districts Ivermectin treatment has been consistent in these co-endemic areas

8 Therapeutic Coverage Region Upper East Upper West Central Northern Brong Ahafo Eastern Ashanti Western Volta

9 Other NTD programs STH pilot program started school de-worming in 2 districts and a nationwide de-worming exercise started in Feb 2007 till date National MDA for schisto is expected to start in all endemic districts in 2011

10 DOLF work

11 Objectives of DOLF Study new drug regimens and treatment schedules for Oncho with a randomized clinical trial 1. IVM 150ug/kg every 12mo X2 (standard) 2. IVM 150ug/kg +ALB 400mg every 12 mo X2 3. IVM 150ug/kg +ALB 400mg every 6 mo X4 4. IVM 150ug/kg+ALB 800mg every 12 mo X2 5. IVM 150ug/kg+ALB 800mg every 6 mo X4 Objective 2 will be completion of the RCT with analysis of data from the 36 month time point.

12 Center of Infectiology and Infection Protection, Medical Faculty, Rheinische Friedrich-Wilhelms-Universität Bonn Director and PI clinical trials: Prof. Achim Hoerauf Focus on: - Scientific & diagnostic services - Teaching - Clinical trials (human and animal studies)

13 KWAME NKRUMAH UNIVERSITY OF SCIENCE AND TECHNOLOGY, KNUST AND KUMASI CENTRE FOR COLLABORATIVE RESEARCH IN TROPICAL MEDICINE, KCCR KCCR NYANSAP C W C S A N E N O BADWEMMA KNUST

14 KCCR Kumasi Center for Collaborative Research Labs equipped with e.g.: -Microscopes -Biosafety hoods -Cooled centrifuges -ELISA reader -qpcr cycler -Electrophoresis -Minus 80 C freezers -Liquid nitrogen tanks A fleet of 12 four-wheel vehicles under the supervision of a maintenance unit

15 Other facilities Cafeteria Laboratory space and offices Guest house 4-wheel-drive vehicles

16 Molecular Biology lab - PCR machines Safety hood for PCR mastermix Thermal cyclers Light cycler Cobert Machine

17 Staff available for research work and performance of clinical trials - Kumasi Scientific staff: Dr. Alex Debrah, PhD Yeboah Marfo Debrekyei, MSc Linda Batsa, MSc, PhD student Alex Kwarteng, MSc, PhD student Jubin Osei Mensah, BSc Kenneth Bentum Otabil, BSc Lilian Duku, BSc Henry Hanson, lab technician Health personnel: Gracia Asiedu, registered nurse Asamoah Asare, registered nurse Mavis Oppong Boatemaa, registered nurse MD s Dr. Peter Konadu, surgeon, Head, Emergency Unit Dr. Sunny Mante, surgeon, co-ordinator of the West African Morbidity Program in LF Research assistant: Yusif Mubarik, field logistics Supporting staff: Wiredu Seth, field assistance and driver Emmanuel Larey, field assistance and driver Philipp Boatin, field assistance and driver Paul Boateng, field assistance and driver Senyo, car technician Ruth Boateng, cook

18 KCCR research sites

19 Accomodation facilities: -12 bed rooms - Office - store rooms - watchmen/security area - parking lot

20 Study site Dunkwa on Offin - lab Equipped with e.g. : - running water/electricity + generator as back-up - microscopes - biosafety hood - fridges - liquid nitrogen tank - hot air sterilizer

21 Doxycycline 6 weeks 100mg/d 60 patients

22 Experience -human clinical trials collaboration Kumasi and Bonn Collaboration since 1998 Number of clinical trials: - onchocerciasis 7 - lymphatic filariasis 9 total 16 Number of participating patients: > 2000 Research team underwent training in Good Clinical Practice GCP), performed by A.Debrah and S. Mand (both certified according to ICH-GCP) ICH=International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use

23 Study sites onchoceriasis - Upper and Lower Denkyira District, Amansie Central and Adanse South Districts, - 43 villages: - region: south of Offin (18 villages) - Study population: - men and women - age: years

24 Study area Upper and Lower Denkyira District along the river Offin

25 Explanation in the villages

26 Palpation of onchocercomata

27

28

29 Operating theater: -Air conditioned - sterile working conditions - ward with 12 beds available Nodulectomies in local anaesthesia

30 Region: Number of nodule-positive patients per total number palpated Village Code Total Count Nod Nod + Nod + (%) % % % % % % 015/ % % % % % 054/ % % % % All: % Comment: in these villages volunteers know the disease onchocerciasis and are aware of the symptoms (onchocercomata ) from former studies.

31 Number of Mf-positive patients per total number of nodule-positive Village Code Total Count Mf Mf + Mf + (%) Median (Mf/mg) 25 th percentile 10 th percentile % % % % % ,6% % / % % % % % / % % % % All: %

32 Mf-count 2200 palpated volunteers (based on the fact that in most villages approx. 55% were nodule-negative) 961 nodule-positive volunteers (aged years) 737 had at least 2 palpable nodules 187 had 1 palpable nodule 37 had palpable nodules but were excluded for not meeting inclusion criteria (number of nodules not available) 831 were snipped 678 Mf-positive 153 Mf-negative IVM rounds N = no IVM 1 round 2 rounds 3 rounds 5 rounds 10 Mf/mg Mf/mg Mf/mg Mf/mg Mf/mg Mf/mg > 0 Mf/mg In 120 cases one or more information were lacking. These patients were either excluded from the study for not meeting inclusion criteria or did not come to a 2 nd survey.

33 Mf-count 205/ 2200 (9.3%) approx. every 11 th volunteer would be eligible if entry criteria: Mf/mg 10 and not more than 2 IVM-rounds IVM rounds N = no IVM 1 round 2 rounds 3 rounds 5 rounds 10 Mf/mg Mf/mg Mf/mg Mf/mg Mf/mg Mf/mg > 0 Mf/mg

34 Mf-count 205/ 2200 (9.3%) approx. every 11 th volunteer would be eligible if entry criteria: Mf/mg 10 and not more than 2 IVM-rounds 254/ 2200 (11.6%) approx. every 8 th -9 th volunteer would be eligible if entry criteria: Mf/mg 5 and not more than 2 IVM-rounds IVM rounds N = no IVM 1 round 2 rounds 3 rounds 5 rounds 10 Mf/mg Mf/mg Mf/mg Mf/mg Mf/mg Mf/mg > 0 Mf/mg

35 Mf-count The recruitment period for the post-doc will last approx. 4 months if entry criteria: Mf/mg 10 and not more than 2 IVM-rounds Months of recruitment IVM rounds no IVM 1 round 2 rounds 3 rounds 5 rounds 10 Mf/mg Mf/mg Mf/mg Mf/mg Mf/mg Mf/mg > 0 Mf/mg Recruitment period in total will be + 1 months for preparation of field, lab and information to villages as well as final visit and sample processing.

36 Mf-count The recruitment period for the post-doc will last approx. 4 months if entry criteria: Mf/mg 10 and not more than 2 IVM-rounds The recruitment period for the post-doc will last approx. 3.2 months if entry criteria: Mf/mg 5 and not more than 2 IVM-rounds Months of recruitment IVM rounds no IVM 1 round 2 rounds 3 rounds 5 rounds 10 Mf/mg Mf/mg Mf/mg Mf/mg Mf/mg Mf/mg > 0 Mf/mg

37

38 Acknowledgement Thanks to Ghana MOH of the data Dr. Nana Biritwum

39

40 Endpoints Skin Mf level pre-treatment and 6,12,18,24,30, and 36 months Embryogenesis and adult worm viability at 36 months