Doxycycline to improve lymphedema due to podoconiosis
- Conditions
- Podoconiosis (Podo)Injury, Occupational Diseases, PoisoningLymphoedema, not elsewhere classified
- Registration Number
- ISRCTN11881662
- Lead Sponsor
- niversity of Buea
- Brief Summary
2020 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/32228663 protocol (added 02/04/2020)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 203
Current participant inclusion criteria as of 07/05/2019:
1. Lymphedema of at least one leg grade 2-3 measured on a 5-point scale (Tekola et al, 2008)
2. Age = 18 years and = 60 years
3. Men or non-pregnant women. If women of childbearing-potential, they must use an approved, effective method of contraception (including abstinence) before, during and for at least 2 weeks after the completion of the active intervention with doxycycline or placebo
4. Negative pregnancy test
5. Body weight = 40 kg
6. Resident in endemic area for podoconiosis for = 2 years
7. Able and willing to give informed consent/ to provide assent to participate in the trial
8. Ability to use established standardized methods of hygiene and effectively applying it prior to the initiation of the drug treatment
9. Negative test for lymphatic filariasis (LF)
Previous participant inclusion criteria:
1. Lymphedema of at least one leg grade 2-4 measured on a 5-point scale (Tekola et al, 2008)
2. Age = 18 years and = 65 years
3. Men or non-pregnant women. If women of childbearing-potential, they must use an approved, effective method of contraception (including abstinence) before, during and for at least 2 weeks after the completion of the active intervention with doxycycline or placebo
4. Negative pregnancy test
5. Body weight = 40 kg
6. Resident in endemic area for podoconiosis for = 2 years
7. Able and willing to give informed consent/ to provide assent to participate in the trial
8. Ability to use established standardized methods of hygiene and effectively applying it prior to the initiation of the drug treatment
9. Negative test for lymphatic filariasis (LF)
Current participant exclusion criteria as of 07/05/2019:
1.No lymphedema
2.Stage 1, 4 or stage 5 lymphedema due to podoconiosis
3.Lymphedema due to lymphatic filariasis (LF)
4.Age < 18 years or > 60 years
5.Body weight < 40 kg
6.Pregnant or breastfeeding women
7.Women of childbearing potential not using an agreed method of contraception (including abstinence; oral contraceptives are not allowed because of interaction with trial drugs)
8.Clinical or biologic evidence of hepatic or renal dysfunction or disease of the central nervous system (CNS)
9.Evidence of severe comorbidities except for features of filarial disease
10.Alcohol or drug abuse
11.History of adverse reactions to doxycycline or other tetracyclines
12.Any significant condition (including medical and psychological/ psychiatric disorder) which in the opinion of the study investigator might interfere with the conduct of the study
13.History of photosensitivity reactions after taking drugs.
14.Concomitant medication with antacids containing aluminium, magnesium or sucralfate and not able to discontinue
15.Concomitant medication with other antibiotics than doxycycline and not able to discontinue
16.Concomitant medication with diuretics or sulfonylurea
17.Concomitant medication with coumarin
18.Haemoglobin < 8 gm/dL
19.Neutrophil count <1 100/mm3
20.Platelet count <100 000/mm3
21.Creatinine > 2 times upper limit of normal
22.AST (GOT) > 2 times upper limit of normal
23.ALT (GPT) > 2 times upper limit of normal
24.Gamma-GT > 2 times upper limit of normal
25.Positive urine pregnancy test
26.Positive test for W. bancrofti
Previous participant exclusion criteria:
1. No lymphedema, stage 1 or stage 5 lymphedema due to podoconiosis
2. Lymphedema due to lymphatic filariasis (LF)
3. Age < 18 years or > 65 years
4. Body weight < 40 kg
5. Pregnant or breastfeeding women
6. Women of childbearing potential not using an agreed method of contraception (including abstinence; oral contraceptives are not allowed because of interaction with trial drugs)
7. Clinical or biologic evidence of hepatic or renal dysfunction or disease of the central nervous system (CNS)
8. Evidence of severe comorbidities except for features of filarial disease
9. Alcohol or drug abuse
10. History of adverse reactions to doxycycline or other tetracyclines
11. Any significant condition (including medical and psychological/ psychiatric disorder) which in the opinion of the study investigator might interfere with the conduct of the study
12. History of photosensitivity reactions after taking drugs.
13. Concomitant medication with antacids containing aluminium, magnesium or sucralfate and not able to discontinue
14. Concomitant medication with other antibiotics than doxycycline and not able to discontinue
15. Concomitant m
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ack of progression of lymphedema due to podoconiosis (PodoLE) (stage reduction or same stage as pre-treatment using the 5-point scale staging according to Tekola et al, 2008), examined 24 months after treatment onset
- Secondary Outcome Measures
Name Time Method