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Table 2 Inclusion and exclusion criteria

From: The design and development of a multicentric protocol to investigate the impact of adjunctive doxycycline on the management of peripheral lymphoedema caused by lymphatic filariasis and podoconiosis

Study selection criteriaDefinition
Clinical inclusion criteriaAge ≥ 14 years and ≤ 65 years
Male or non-pregnant woman of childbearing-potential using an approved, effective method of contraception before, during and for at least 2 weeks after the completion of the active intervention with doxycycline or placebo
Able to give informed consent/assent to participate in the trial
Resident in an LF endemic area for five years (> 2 years for TAKeOFF)
Body weight ≥ 40 kg
Lymphoedema of at least one limb Stage 1-6 measured on a 7-point scale. (Stage 2 or 3 for podoconiosis)
Ability to use established standardized methods of hygiene and effectively applying it prior to initiation of drug treatment
No evidence of severe or systemic co-morbidities (except for features of filarial disease)
Normal laboratory profile (type of investigations and normal limits in the case of haematological abnormalities are site-specific)
Consent to storage of blood samples for further study (site specific)
Negative pregnancy test
Clinical exclusion criteriaNo lymphoedema or lymphoedema stage 7
Age < 14 years or > 65 years
Body weight < 40 kg
Pregnant or breastfeeding women
Women of childbearing potential not using an agreed method of contraception
Clinical or laboratory evidence of hepatic or renal dysfunction or CNS disease
Alcohol or drug abuse
History of adverse reactions to doxycycline or other tetracyclines
Patient has any situation or condition that may interfere with participation in the study as judged by the clinical investigator
History of photosensitivity reactions after taking drugs
Concomitant medication with antacids containing aluminium, magnesium or sucralfate and not able to discontinue
Concomitant medication with other antibiotics than doxycycline and not able to discontinue
Concomitant medication with diuretics or sulfonylurea or coumarin
Laboratory exclusion criteriaHaemoglobin < 8 g/dl
Neutrophil count < 1100/mm3
Platelet count < 100,000/mm3
Creatinine > 2 times upper limit of normal
AST (GOT), ALT (GPT), gamma-GT > 2 times upper limit of normal
Positive urine pregnancy test